Cleared Traditional

K925677 - AUTOCHILL ACCESSORY KIT (FDA 510(k) Clearance)

K925677 · Aircast, Inc. · Physical Medicine device

Apr 1993

Decision

272d

Days

Class 2

Risk

K925677 is an FDA 510(k) clearance for the AUTOCHILL ACCESSORY KIT. This device is classified as a Pack, Hot Or Cold, Water Circulating (Class II - Special Controls, product code ILO).

Submitted by Aircast, Inc. (Summit, US). The FDA issued a Cleared decision on April 14, 1993, 272 days after receiving the submission on July 16, 1992.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5720.

Submission Details

510(k) Number	K925677 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 16, 1992
Decision Date	April 14, 1993
Days to Decision	272 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement