part_subject: "GENERAL HOSPITAL AND PERSONAL USE DEVICES"
subpart_code: "C"
subpart_subject: "General Hospital and Personal Use Monitoring Devices"
section_number: "880.2930"
section_subject: "Apgar timer."
cfr_reference: "21 CFR 880.2930"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 800 to 1299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
---
(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.