Cleared Traditional

MICROTIME

K952616 · Westmed Intl. · Anesthesiology
Sep 1995
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K952616 is an FDA 510(k) clearance for the MICROTIME, a Compressor, Air, Portable (Class II — Special Controls, product code BTI), submitted by Westmed Intl. (Tucson, US). The FDA issued a Cleared decision on September 27, 1995, 113 days after receiving the submission on June 6, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.6250.

Submission Details

510(k) Number K952616 FDA.gov
FDA Decision Cleared SESE
Date Received June 06, 1995
Decision Date September 27, 1995
Days to Decision 113 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