BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    CARDIO SERV

    K Number: K951110 · Decision Sep 15, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    165
    Applicant Total
    2
    Review Days
    189

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    Basic Information

    Device Name
    CARDIO SERV
    K Number
    K951110
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hellige GmbH
    Date Received
    March 10, 1995
    Decision Date
    September 15, 1995
    Product Code
    LDD
    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
    LDD Dc-Defibrillator, Low-Energy, (Including Paddles)

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