Cleared Traditional

PM14 SOFT AIR COMPRESSOR

K902762 · Precision Medical, Inc. · Anesthesiology
Jul 1990
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K902762 is an FDA 510(k) clearance for the PM14 SOFT AIR COMPRESSOR, a Compressor, Air, Portable (Class II — Special Controls, product code BTI), submitted by Precision Medical, Inc. (Northampton, US). The FDA issued a Cleared decision on July 30, 1990, 35 days after receiving the submission on June 25, 1990. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.6250.

Submission Details

510(k) Number K902762 FDA.gov
FDA Decision Cleared SESE
Date Received June 25, 1990
Decision Date July 30, 1990
Days to Decision 35 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