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

    VENAPULSE MODELS VP-25 AND VP-50

    K Number: K903894 · Decision Apr 3, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    6
    Review Days
    223

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    Basic Information

    Device Name
    VENAPULSE MODELS VP-25 AND VP-50
    K Number
    K903894
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Aci Medical, Inc.
    Date Received
    August 23, 1990
    Decision Date
    April 3, 1991
    Product Code
    JOW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JOW Sleeve, Limb, Compressible

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    Other Clearances by Aci Medical, Inc.

    K Number Device Name
    K942530 ART-ASSIST MODEL AA-1000
    K903532 UNNA-SLEEVE(TM)
    K881291 AIR PLETHYSMOGRAPH MODEL APG-1000
    K861645 MICRO-TRACHEOSTOMY CARE KIT
    K844309 IV RATEMETER