Cleared Traditional

OMBRA TABLE TOP COMPRESSOR

K131881 · Trudell Medical Intl. · Anesthesiology
Oct 2013
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K131881 is an FDA 510(k) clearance for the OMBRA TABLE TOP COMPRESSOR, a Compressor, Air, Portable (Class II — Special Controls, product code BTI), submitted by Trudell Medical Intl. (London, CA). The FDA issued a Cleared decision on October 24, 2013, 121 days after receiving the submission on June 25, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.6250.

Submission Details

510(k) Number K131881 FDA.gov
FDA Decision Cleared SESE
Date Received June 25, 2013
Decision Date October 24, 2013
Days to Decision 121 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