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

    HEALTHCARE SERVICE & SUPPLY PUMP ALP 501 PUMP SYSTEM

    K Number: K955853 · Decision Jun 25, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    4
    Review Days
    187

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    Basic Information

    Device Name
    HEALTHCARE SERVICE & SUPPLY PUMP ALP 501 PUMP SYSTEM
    K Number
    K955853
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Healthcare Service and Supply
    Date Received
    December 21, 1995
    Decision Date
    June 25, 1996
    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 Healthcare Service and Supply

    K Number Device Name
    K000303 HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GARMENTS FOR THE LIMB
    K974318 HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GAARMENTS FOR THE LIMB
    K964188 HEALTHCARE SERVICE AND SUPPLY PVA (PNEUMATIC VENOUS AUGMENTATION) FOOT GARMENT