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

    BRATTLE R-DETECT PHYSIOLOGICAL SYNCHRONIZERS

    K Number: K828565 · Decision Jan 3, 1983
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    75

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    Basic Information

    Device Name
    BRATTLE R-DETECT PHYSIOLOGICAL SYNCHRONIZERS
    K Number
    K828565
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Applicant
    Medical Electronics Corp.
    Date Received
    October 20, 1982
    Decision Date
    January 3, 1983
    Advisory Committee
    Unknown
    Review Advisory Committee
    RA
    Third Party
    N

    Other Clearances by Medical Electronics Corp.

    K Number Device Name
    K831577 TRACHEA/CUFF INFLATOR W/PRESSURE #583