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Title 21 Part 880 → Subpart C → §880.2400

Title 21 → Chapter I → Subchapter H → Part 880 → Subpart C → §880.2400

Electronic Code of Federal Regulations e-CFR

Title 21 Part 880 → Subpart C → §880.2400

e-CFR data is current as of November 12, 2019

Title 21Chapter ISubchapter HPart 880Subpart C → §880.2400


Title 21: Food and Drugs
PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
Subpart C—General Hospital and Personal Use Monitoring Devices


§880.2400   Bed-patient monitor.

(a) Identification. A bed-patient monitor is a battery-powered device placed under a mattress and used to indicate by an alarm or other signal when a patient attempts to leave the bed.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001]


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