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

    ASPIRATOR, CONTINUOUS & PROGRAMMABLE INTERMITTENT

    K Number: K951423 · Decision Apr 18, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    158
    Applicant Total
    27
    Review Days
    22

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    Basic Information

    Device Name
    ASPIRATOR, CONTINUOUS & PROGRAMMABLE INTERMITTENT
    K Number
    K951423
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Impact Instrumentation, Inc.
    Date Received
    March 27, 1995
    Decision Date
    April 18, 1995
    Product Code
    BTA
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BTA Pump, Portable, Aspiration (Manual Or Powered)

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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
    K032386 UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)
    K022062 IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00
    K941096 ELECTRIC VACUM PUMP
    K931473 IMPACT MODEL 753
    Search all 27 clearances from Impact Instrumentation, Inc. →