Title 21: Food and Drugs
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/ PART 880 - GENERAL HOSPITAL AND PERSONAL USE DEVICES
/ Subpart G - General Hospital and Personal Use Miscellaneous Devices / § 880.6080 Cardiopulmonary resuscitation board.
§ 880.6080 Cardiopulmonary resuscitation board.
(a) Identification. A cardiopulmonary resuscitation board is a device consisting of a rigid board which is placed under a patient to act as a support during cardiopulmonary resuscitation.
(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 of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.