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

    AMPLIFIER MODULE, 78211A ECG

    K Number: K772132 · Decision Nov 22, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    23
    Applicant Total
    230
    Review Days
    8

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    Basic Information

    Device Name
    AMPLIFIER MODULE, 78211A ECG
    K Number
    K772132
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2050
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Hewlett-Packard Co.
    Date Received
    November 14, 1977
    Decision Date
    November 22, 1977
    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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