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

    BIOMETRIC ERG SYSTEM

    K Number: K802472 · Decision Nov 26, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    397
    Applicant Total
    2
    Review Days
    48

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    Basic Information

    Device Name
    BIOMETRIC ERG SYSTEM
    K Number
    K802472
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Biometric Analysis Group, Inc.
    Date Received
    October 9, 1980
    Decision Date
    November 26, 1980
    Product Code
    DSI
    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
    DSI Detector And Alarm, Arrhythmia

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    Other Clearances by Biometric Analysis Group, Inc.

    K Number Device Name
    K802198 BIOMETRIC SYSTOLIC TIME INTERVAL SYSTEM