BEUDAMED
    FDA 510(k) FDA class 1 Unknown 🇩🇪 Germany

    H5000, H5000L, H5000L REVERSE MODEL H5000C, H5000CG

    K Number: K946043 · Decision Mar 8, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    228
    Same Product Code
    55
    Applicant Total
    30
    Review Days
    86

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    Basic Information

    Device Name
    H5000, H5000L, H5000L REVERSE MODEL H5000C, H5000CG
    K Number
    K946043
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4770
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Rudolf Riester GmbH & Co. KG
    Date Received
    December 12, 1994
    Decision Date
    March 8, 1995
    Product Code
    ERA
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ERA Otoscope

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