BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    GENERATOR, R-WAVE

    K Number: K790213 · Decision Mar 22, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    51

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    GENERATOR, R-WAVE
    K Number
    K790213
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1410
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Amr Co.
    Date Received
    January 30, 1979
    Decision Date
    March 22, 1979
    Product Code
    IYY
    Advisory Committee
    Radiology
    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
    IYY Synchronizer, Electrocardiograph, Nuclear

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (IYY), ordered by most recent decision date.

    VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM)

    FDA 510(k)
    FDA Class 1 ·Radiology

    NUCLEAR STETHOSCOPE

    FDA 510(k)
    FDA Class 1 ·Radiology
    View all