Cleared Traditional

UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV

K071526 · Impact Instrumentation, Inc. · Anesthesiology
Dec 2008
Decision
555d
Days
Class 2
Risk

About This 510(k) Submission

K071526 is an FDA 510(k) clearance for the UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV, 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 December 10, 2008, 555 days after receiving the submission on June 4, 2007. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K071526 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 2007
Decision Date December 10, 2008
Days to Decision 555 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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