Cleared Traditional

MINIMATE COMPRESSOR

K051691 · Precision Medical, Inc. · Anesthesiology
Dec 2005
Decision
169d
Days
Class 2
Risk

About This 510(k) Submission

K051691 is an FDA 510(k) clearance for the MINIMATE 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 December 9, 2005, 169 days after receiving the submission on June 23, 2005. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.6250.

Submission Details

510(k) Number K051691 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 2005
Decision Date December 09, 2005
Days to Decision 169 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

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