Cleared Traditional

MEDICAL AIR COMPRESSOR

K113338 · Oricare, Inc. · Anesthesiology
Aug 2012
Decision
270d
Days
Class 2
Risk

About This 510(k) Submission

K113338 is an FDA 510(k) clearance for the MEDICAL AIR COMPRESSOR, a Compressor, Air, Portable (Class II — Special Controls, product code BTI), submitted by Oricare, Inc. (Quakertow., US). The FDA issued a Cleared decision on August 10, 2012, 270 days after receiving the submission on November 14, 2011. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.6250.

Submission Details

510(k) Number K113338 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 2011
Decision Date August 10, 2012
Days to Decision 270 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