Cleared Traditional

UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR

K111473 · Impact Instrumentation, Inc. · Anesthesiology
Feb 2012
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K111473 is an FDA 510(k) clearance for the UNI-VENT (R) MODEL 731 SERIES 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 February 16, 2012, 265 days after receiving the submission on May 27, 2011. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K111473 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 2011
Decision Date February 16, 2012
Days to Decision 265 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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