§ 890.5940. Chilling unit.
75 words·~1 min read·
/us/cfr/t21/s§ 890.5940·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A chilling unit is a refrigerative device intended for medical purposes to chill and maintain cold packs at a reduced temperature.
(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 § 890.9 [48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38818, July 25, 2001]