Cleared Traditional

UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)

K032386 · Impact Instrumentation, Inc. · Anesthesiology
Mar 2004
Decision
235d
Days
Class 2
Risk

About This 510(k) Submission

K032386 is an FDA 510(k) clearance for the UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR), a Ventilator, Emergency, Powered (resuscitator) (Class II — Special Controls, product code BTL), submitted by Impact Instrumentation, Inc. (West Caldwell, US). The FDA issued a Cleared decision on March 26, 2004, 235 days after receiving the submission on August 4, 2003. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5925.

Submission Details

510(k) Number K032386 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 2003
Decision Date March 26, 2004
Days to Decision 235 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTL — Ventilator, Emergency, Powered (resuscitator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5925

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