FDA 21 CFR Part 868 Anesthesiology Devices

FDA 21 CFR Part 868 Anesthesiology Devices:

FDA 21 CFR Part 868 Anesthesiology Devices: (a) This part sets forth the classification of anesthesiology devices intended for human use that are in commercial distribution.

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Table of contents

Subpart A - General Provisions

868.1 Scope.

868.3 Effective dates of requirement for premarket approval.

868.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Subpart B - Diagnostic Devices

868.1030 Manual algesimeter.

868.1040 Powered algesimeter.

868.1075 Argon gas analyzer.

868.1100 Arterial blood sampling kit.

868.1120 Indwelling blood oxyhemoglobin concentration analyzer.

868.1150 Indwelling blood carbon dioxide partial pressure (P2CO2) analyzer.

868.1170 Indwelling blood hydrogen ion concentration (pH) analyzer.

868.1200 Indwelling blood oxygen partial pressure (PO2) analyzer.

868.1400 Carbon dioxide gas analyzer.

868.1430 Carbon monoxide gas analyzer.

868.1500 Enflurane gas analyzer.

868.1505 Ventilatory electrical impedance tomograph.

868.1575 Gas collection vessel.

868.1620 Halothane gas analyzer.

868.1640 Helium gas analyzer.

868.1670 Neon gas analyzer.

868.1690 Nitrogen gas analyzer.

868.1700 Nitrous oxide gas analyzer.

868.1720 Oxygen gas analyzer.

868.1730 Oxygen uptake computer.

868.1750 Pressure plethysmograph.

868.1760 Volume plethysmograph.

868.1780 Inspiratory airway pressure meter.

868.1800 Rhinoanemometer.

868.1840 Diagnostic spirometer.

868.1850 Monitoring spirometer.

868.1860 Peak-flow meter for spirometry.

868.1870 Gas volume calibrator.

868.1880 Pulmonary-function data calculator.

868.1890 Predictive pulmonary-function value calculator.

868.1900 Diagnostic pulmonary-function interpretation calculator.

868.1910 Esophageal stethoscope.

868.1920 Esophageal stethoscope with electrical conductors.

868.1930 Stethoscope head.

868.1965 Switching valve (ploss).

868.1975 Water vapor analyzer.

Subpart C - Monitoring Devices

Subparts D-E [Reserved], (and)

Subpart F - Therapeutic Devices

FDA 21 CFR Part 868 Anesthesiology Devices:

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