Cleared Traditional

K852622 - AEROSOL ONE
(FDA 510(k) Clearance)

K852622 · Ashai Co. , Ltd. · Anesthesiology
Apr 1986
Decision
308d
Days
Class 2
Risk

K852622 is an FDA 510(k) clearance for the AEROSOL ONE, a Compressor, Air, Portable (Class II — Special Controls, product code BTI), submitted by Ashai Co. , Ltd. (Australia, AU). The FDA issued a Cleared decision on April 24, 1986, 308 days after receiving the submission on June 20, 1985. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.6250.

Submission Details

510(k) Number K852622 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 1985
Decision Date April 24, 1986
Days to Decision 308 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BTI — Compressor, Air, Portable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.6250