Cleared Traditional

UNI-VENT(TM) IMPACT MINUTE VOLUME VENTILATOR

K870861 · Impact Instrumentation, Inc. · Anesthesiology
Jan 1988
Decision
322d
Days
Class 2
Risk

About This 510(k) Submission

K870861 is an FDA 510(k) clearance for the UNI-VENT(TM) IMPACT MINUTE VOLUME 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 January 19, 1988, 322 days after receiving the submission on March 3, 1987. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K870861 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 1987
Decision Date January 19, 1988
Days to Decision 322 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

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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