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Title 21 Part 880 → Subpart C → §880.2930

Title 21 → Chapter I → Subchapter H → Part 880 → Subpart C → §880.2930

Electronic Code of Federal Regulations e-CFR

Title 21 Part 880 → Subpart C → §880.2930

e-CFR data is current as of September 19, 2019

Title 21Chapter ISubchapter HPart 880Subpart C → §880.2930


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


§880.2930   Apgar timer.

(a) Identification. The Apgar timer is a device intended to alert a health care provider to take the Apgar score of a newborn infant.

(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. The device is also exempt from the current good manufacturing practice requirements in part 820 of this chapter, with the exception of §820.180 of this chapter, with respect to general requirements concerning records, and §820.198 of this chapter, with respect to complaint files.

[63 FR 59718, Nov. 5, 1998]