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

    BETATRON IV SYSTEM

    K Number: K872774 · Decision Jan 5, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    76
    Review Days
    175

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    Basic Information

    Device Name
    BETATRON IV SYSTEM
    K Number
    K872774
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Cardiac Pacemakers, Inc.
    Date Received
    July 14, 1987
    Decision Date
    January 5, 1988
    Product Code
    FRN
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FRN Pump, Infusion

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    Other Clearances by Cardiac Pacemakers, Inc.

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    K905674 LEAD STYLET
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    K890785 ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE
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