Cleared Traditional

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

K091238 · Impact Instrumentation, Inc. · Anesthesiology
Aug 2009
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K091238 is an FDA 510(k) clearance for the UNI-VENT-731 SERIES VENTILATORS, MODEL 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 August 13, 2009, 108 days after receiving the submission on April 27, 2009. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K091238 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 2009
Decision Date August 13, 2009
Days to Decision 108 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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