Cleared Traditional

AEROSOL ONE, NEBULIZER PUMP

K870428 · Ashai Co. , Ltd. · Anesthesiology
May 1987
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K870428 is an FDA 510(k) clearance for the AEROSOL ONE, NEBULIZER PUMP, 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 May 15, 1987, 101 days after receiving the submission on February 3, 1987. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.6250.

Submission Details

510(k) Number K870428 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 1987
Decision Date May 15, 1987
Days to Decision 101 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