BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)

    K Number: K032386 · Decision Mar 26, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    99
    Applicant Total
    27
    Review Days
    235

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    Basic Information

    Device Name
    UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)
    K Number
    K032386
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5925
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Impact Instrumentation, Inc.
    Date Received
    August 4, 2003
    Decision Date
    March 26, 2004
    Product Code
    BTL
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BTL Ventilator, Emergency, Powered (Resuscitator)

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    Other Clearances by Impact Instrumentation, Inc.

    K Number Device Name
    K133196 IMPACT MODEL 323 ASPIRATOR
    K111473 UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR
    K103318 UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR
    K091238 UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+
    K071526 UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV
    K051476 UNI-VENT MODEL 73X
    K022062 IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00
    K951423 ASPIRATOR, CONTINUOUS & PROGRAMMABLE INTERMITTENT
    K941096 ELECTRIC VACUM PUMP
    K931473 IMPACT MODEL 753
    Search all 27 clearances from Impact Instrumentation, Inc. →