Cleared Traditional

UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR

K103318 · Impact Instrumentation, Inc. · Anesthesiology
Apr 2011
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K103318 is an FDA 510(k) clearance for the UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Impact Instrumentation, Inc. (West Caldwell, US). The FDA issued a Cleared decision on April 7, 2011, 146 days after receiving the submission on November 12, 2010. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K103318 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 2010
Decision Date April 07, 2011
Days to Decision 146 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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