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FEDERAL · 21 CFR

Part 868 — Anesthesiology Devices

154 sections · Title 21: Food and Drugs

§ 868.1Scope.
§ 868.3Effective dates of requirement for premarket approval.
§ 868.9Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
§ 868.1030Manual algesimeter.
§ 868.1040Powered algesimeter.
§ 868.1075Argon gas analyzer.
§ 868.1100Arterial blood sampling kit.
§ 868.1120Indwelling blood oxyhemoglobin concentration analyzer.
§ 868.1150Indwelling blood carbon dioxide partial pressure (P<sub>2CO2</sub>) analyzer.
§ 868.1170Indwelling blood hydrogen ion concentration (pH) analyzer.
§ 868.1200Indwelling blood oxygen partial pressure (P<sub>O2</sub>) analyzer.
§ 868.1400Carbon dioxide gas analyzer.
§ 868.1430Carbon monoxide gas analyzer.
§ 868.1500Enflurane gas analyzer.
§ 868.1505Ventilatory electrical impedance tomograph.
§ 868.1575Gas collection vessel.
§ 868.1620Halothane gas analyzer.
§ 868.1640Helium gas analyzer.
§ 868.1670Neon gas analyzer.
§ 868.1690Nitrogen gas analyzer.
§ 868.1700Nitrous oxide gas analyzer.
§ 868.1720Oxygen gas analyzer.
§ 868.1730Oxygen uptake computer.
§ 868.1750Pressure plethysmograph.
§ 868.1760Volume plethysmograph.
§ 868.1780Inspiratory airway pressure meter.
§ 868.1800Rhinoanemometer.
§ 868.1840Diagnostic spirometer.
§ 868.1850Monitoring spirometer.
§ 868.1860Peak-flow meter for spirometry.
§ 868.1870Gas volume calibrator.
§ 868.1880Pulmonary-function data calculator.
§ 868.1890Predictive pulmonary-function value calculator.
§ 868.1900Diagnostic pulmonary-function interpretation calculator.
§ 868.1910Esophageal stethoscope.
§ 868.1920Esophageal stethoscope with electrical conductors.
§ 868.1930Stethoscope head.
§ 868.1965Switching valve (ploss).
§ 868.1975Water vapor analyzer.
§ 868.1980Real-time ultrasound anatomy visualization and labeling device for ultrasound guided regional anesthesia.
§ 868.2025Ultrasonic air embolism monitor.
§ 868.2200Adjunctive pain measurement device for anesthesiology.
§ 868.2250Monitor for opioid induced impairment of oxygenation.
§ 868.2300Bourdon gauge flowmeter.
§ 868.2320Uncompensated thorpe tube flowmeter.
§ 868.2340Compensated thorpe tube flowmeter.
§ 868.2350Gas calibration flowmeter.
§ 868.2375Breathing frequency monitor.
§ 868.2376Device for sleep apnea testing based on mandibular movement.
§ 868.2377Apnea monitor.
§ 868.2380Nitric oxide analyzer.
§ 868.2385Nitrogen dioxide analyzer.
§ 868.2450Lung water monitor.
§ 868.2480Cutaneous carbon dioxide (PcCO2) monitor.
§ 868.2500Cutaneous oxygen (PcO2) monitor.
§ 868.2550Pneumotachometer.
§ 868.2600Airway pressure monitor.
§ 868.2610Gas pressure gauge.
§ 868.2620Gas pressure calibrator.
§ 868.2700Pressure regulator.
§ 868.2775Electrical peripheral nerve stimulator.
§ 868.2875Differential pressure transducer.
§ 868.2885Gas flow transducer.
§ 868.2900Gas pressure transducer.
§ 868.5090Emergency airway needle.
§ 868.5095Retrograde intubation device.
§ 868.5100Nasopharyngeal airway.
§ 868.5105External negative pressure airway aid.
§ 868.5110Oropharyngeal airway.
§ 868.5115Device to relieve acute upper airway obstruction.
§ 868.5120Anesthesia conduction catheter.
§ 868.5130Anesthesia conduction filter.
§ 868.5140Anesthesia conduction kit.
§ 868.5150Anesthesia conduction needle.
§ 868.5160Gas machine for anesthesia or analgesia.
§ 868.5165Nitric oxide administration apparatus.
§ 868.5170Laryngotracheal topical anesthesia applicator.
§ 868.5180Rocking bed.
§ 868.5220Blow bottle.
§ 868.5240Anesthesia breathing circuit.
§ 868.5250Breathing circuit circulator.
§ 868.5260Breathing circuit bacterial filter.
§ 868.5270Breathing system heater.
§ 868.5273Positive airway pressure delivery system.
§ 868.5280Breathing tube support.
§ 868.5300Carbon dioxide absorbent.
§ 868.5310Carbon dioxide absorber.
§ 868.5320Reservoir bag.
§ 868.5330Breathing gas mixer.
§ 868.5340Nasal oxygen cannula.
§ 868.5350Nasal oxygen catheter.
§ 868.5365Posture chair for cardiac or pulmonary treatment.
§ 868.5375Heat and moisture condenser (artificial nose).
§ 868.5400Electroanesthesia apparatus.
§ 868.5420Ether hook.
§ 868.5430Gas-scavenging apparatus.
§ 868.5440Portable oxygen generator.
§ 868.5450Respiratory gas humidifier.
§ 868.5454High flow humidified oxygen delivery device.
§ 868.5460Therapeutic humidifier for home use.
§ 868.5470Hyperbaric chamber.
§ 868.5480Isocapnic ventilation device.
§ 868.5530Flexible laryngoscope.
§ 868.5540Rigid laryngoscope.
§ 868.5550Anesthetic gas mask.
§ 868.5560Gas mask head strap.
§ 868.5570Nonrebreathing mask.
§ 868.5580Oxygen mask.
§ 868.5590Scavenging mask.
§ 868.5600Venturi mask.
§ 868.5620Breathing mouthpiece.
§ 868.5630Nebulizer.
§ 868.5640Medicinal nonventilatory nebulizer (atomizer).
§ 868.5650Esophageal obturator.
§ 868.5655Portable liquid oxygen unit.
§ 868.5665Powered percussor.
§ 868.5675Rebreathing device.
§ 868.5690Incentive spirometer.
§ 868.5700Nonpowered oxygen tent.
§ 868.5710Electrically powered oxygen tent.
§ 868.5720Bronchial tube.
§ 868.5730Tracheal tube.
§ 868.5740Tracheal/bronchial differential ventilation tube.
§ 868.5750Inflatable tracheal tube cuff.
§ 868.5760Cuff spreader.
§ 868.5770Tracheal tube fixation device.
§ 868.5780Tube introduction forceps.
§ 868.5790Tracheal tube stylet.
§ 868.5795Tracheal tube cleaning brush.
§ 868.5800Tracheostomy tube and tube cuff.
§ 868.5810Airway connector.
§ 868.5820Dental protector.
§ 868.5830Autotransfusion apparatus.
§ 868.5860Pressure tubing and accessories.
§ 868.5870Nonrebreathing valve.
§ 868.5880Anesthetic vaporizer.
§ 868.5895Continuous ventilator.
§ 868.5905Noncontinuous ventilator (IPPB).
§ 868.5915Manual emergency ventilator.
§ 868.5925Powered emergency ventilator.
§ 868.5935External negative pressure ventilator.
§ 868.5955Intermittent mandatory ventilation attachment.
§ 868.5965Positive end expiratory pressure breathing attachment.
§ 868.5975Ventilator tubing.
§ 868.5995Tee drain (water trap).
§ 868.6100Anesthetic cabinet, table, or tray.
§ 868.6175Cardiopulmonary emergency cart.
§ 868.6225Nose clip.
§ 868.6250Portable air compressor.
§ 868.6400Calibration gas.
§ 868.6700Anesthesia stool.
§ 868.6810Tracheobronchial suction catheter.
§ 868.6820Patient position support.
§ 868.6885Medical gas yoke assembly.