21 CFR 890.5940 - Chilling unit.

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§ 890.5940 Chilling unit.

(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]

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United States Code

Title 21 published on 2015-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 890 after this date.

  • 2015-11-20; vol. 80 # 224 - Friday, November 20, 2015
    1. 80 FR 72589 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Electric Positioning Chair
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective November 20, 2015.
      21 CFR Part 890