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

    IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00

    K Number: K022062 · Decision May 6, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    13
    Applicant Total
    27
    Review Days
    315

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    Basic Information

    Device Name
    IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00
    K Number
    K022062
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Impact Instrumentation, Inc.
    Date Received
    June 25, 2002
    Decision Date
    May 6, 2003
    Product Code
    MOD
    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
    MOD Accessory To Continuous Ventilator (Respirator)

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    Other Clearances by Impact Instrumentation, Inc.

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    K091238 UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+
    K071526 UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV
    K051476 UNI-VENT MODEL 73X
    K032386 UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)
    K951423 ASPIRATOR, CONTINUOUS & PROGRAMMABLE INTERMITTENT
    K941096 ELECTRIC VACUM PUMP
    K931473 IMPACT MODEL 753
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