FDA 21 CFR Part 880 General Hospital and Personal Use Devices

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Table of contents

Subpart A - General Provisions

880.1 Scope.

880.3 Effective dates of requirement for premarket approval.

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

Subpart B [Reserved]

Subpart C - General Hospital and Personal Use Monitoring Devices

880.2200 Liquid crystal forehead temperature strip.

880.2400 Bed-patient monitor.

880.2420 Electronic monitor for gravity flow infusion systems.

880.2460 Electrically powered spinal fluid pressure monitor.

880.2500 Spinal fluid manometer.

880.2700 Stand-on patient scale.

880.2720 Patient scale.

880.2740 Surgical sponge scale.

880.2750 Image processing device for estimation of external blood loss.

880.2800 Sterilization process indicator.

880.2900 Clinical color change thermometer.

880.2910 Clinical electronic thermometer.

880.2920 Clinical mercury thermometer.

880.2930 Apgar timer.

Subparts D-E [Reserved]

Subpart F - General Hospital and Personal Use Therapeutic Devices, (and)

Subpart G - General Hospital and Personal Use Miscellaneous Devices

FDA 21 CFR Part 880 General Hospital and Personal Use Devices: