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

    HORIZON 9000/HIS OPTION AMPLIFIER

    K Number: K914381 · Decision Jan 28, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    23
    Applicant Total
    34
    Review Days
    117

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    Basic Information

    Device Name
    HORIZON 9000/HIS OPTION AMPLIFIER
    K Number
    K914381
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2050
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mennen Medical, Inc.
    Date Received
    October 3, 1991
    Decision Date
    January 28, 1992
    Product Code
    DRR
    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
    DRR Amplifier And Signal Conditioner, Biopotential

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