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

    CUFF PACER

    K Number: K780703 · Decision Jul 17, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    83

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    Basic Information

    Device Name
    CUFF PACER
    K Number
    K780703
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2025
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Omp Laboratories, Inc.
    Date Received
    April 25, 1978
    Decision Date
    July 17, 1978
    Product Code
    CBA
    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
    CBA Monitor, Air Embolism, Ultrasonic

    Other Clearances by Omp Laboratories, Inc.

    K Number Device Name
    K760402 SYRINGE SET, 3-WAY THERMODILUTIN