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

    ECG AMPLIFIER/R WAVE TRIGGER

    K Number: K771976 · Decision Nov 9, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    23
    Applicant Total
    56
    Review Days
    23

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    Basic Information

    Device Name
    ECG AMPLIFIER/R WAVE TRIGGER
    K Number
    K771976
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2050
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    G.D. Searle and Co.
    Date Received
    October 17, 1977
    Decision Date
    November 9, 1977
    Product Code
    DRR
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    RA
    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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