BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇷 Argentina

    GALIX MODEL MA-6R HOLTER REEL-TO-REEL RECORDER

    K Number: K904176 · Decision Sep 20, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    193
    Applicant Total
    2
    Review Days
    374

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    Basic Information

    Device Name
    GALIX MODEL MA-6R HOLTER REEL-TO-REEL RECORDER
    K Number
    K904176
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Galix Instrumentacion Biomedica
    Date Received
    September 11, 1990
    Decision Date
    September 20, 1991
    Product Code
    DSH
    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
    DSH Recorder, Magnetic Tape, Medical

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    Other Clearances by Galix Instrumentacion Biomedica

    K Number Device Name
    K904177 GALIX MA-6C HOLTER CASSETTE RECORDER