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

    PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE

    K Number: K901332 · Decision May 9, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    29
    Applicant Total
    18
    Review Days
    48

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    Basic Information

    Device Name
    PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE
    K Number
    K901332
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3630
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Biotronik, GmbH & Co.
    Date Received
    March 22, 1990
    Decision Date
    May 9, 1990
    Product Code
    DTC
    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
    DTC Analyzer, Pacemaker Generator Function

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