BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E

    K Number: K850361 · Decision May 1, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    48
    Applicant Total
    19
    Review Days
    91

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    Basic Information

    Device Name
    SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E
    K Number
    K850361
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.1400
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Synectics-Dantec
    Date Received
    January 30, 1985
    Decision Date
    May 1, 1985
    Product Code
    FFT
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FFT Electrode, Ph, Stomach

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    K913817 MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION
    K914624 PH METER, MODIFICATION
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