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

    BLOOD PRESSURE MONITORING KITS,WALRUS

    K Number: K830754 · Decision Aug 12, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    209
    Applicant Total
    6
    Review Days
    155

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    Basic Information

    Device Name
    BLOOD PRESSURE MONITORING KITS,WALRUS
    K Number
    K830754
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Medical Parameters, Inc.
    Date Received
    March 10, 1983
    Decision Date
    August 12, 1983
    Product Code
    DXT
    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
    DXT Injector And Syringe, Angiographic

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    Other Clearances by Medical Parameters, Inc.

    K Number Device Name
    K862190 WALRUS: DOUBLE BALLOON SHUNTING CATHETER
    K844444 ESOPHAGEAL STETHOSCOPE
    K833825 MULTI-LUMEN INTRAVENOUS INFUSION CATH
    K831239 WALRUS PERCUTANEOUS INTRODUCER SET
    K830755 I.V. SETS WALRUS BRAND VARIOUS CONFIGUR-