[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR880.2930]

[Page 412]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 880_GENERAL HOSPITAL AND PERSONAL USE DEVICES--Table of Contents
 
     Subpart C_General Hospital and Personal Use Monitoring Devices
 
Sec. 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 Sec. 880.9. The device is 
also exempt from the current good manufacturing practice requirements in 
part 820 of this chapter, with the exception of Sec. 820.180 of this 
chapter, with respect to general requirements concerning records, and 
Sec. 820.198 of this chapter, with respect to complaint files.

[63 FR 59718, Nov. 5, 1998]

Subparts D-E [Reserved]