Cleared Traditional

CRITICAL CARE VENTILATOR

K120931 · Oricare, Inc. · Anesthesiology
Jun 2013
Decision
436d
Days
Class 2
Risk

About This 510(k) Submission

K120931 is an FDA 510(k) clearance for the CRITICAL CARE VENTILATOR, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Oricare, Inc. (Quakertow., US). The FDA issued a Cleared decision on June 6, 2013, 436 days after receiving the submission on March 27, 2012. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K120931 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 2012
Decision Date June 06, 2013
Days to Decision 436 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CBK — Ventilator, Continuous, Facility Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895

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