BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇩🇪 Germany

    H 5100, H 5200, H 5300

    K Number: K945507 · Decision Dec 9, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    36
    Applicant Total
    30
    Review Days
    30

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    Basic Information

    Device Name
    H 5100, H 5200, H 5300
    K Number
    K945507
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6320
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rudolf Riester GmbH & Co. KG
    Date Received
    November 9, 1994
    Decision Date
    December 9, 1994
    Product Code
    KZF
    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
    KZF Device, Medical Examination, Ac Powered

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