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

    HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M-

    K Number: K101892 · Decision Aug 27, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    172
    Registration Numbers
    172
    Same Product Code
    197
    Applicant Total
    7
    Review Days
    51

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    Basic Information

    Device Name
    HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M-
    K Number
    K101892
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Heine Optotechnik GmbH & Co. KG
    Date Received
    July 7, 2010
    Decision Date
    August 27, 2010
    Product Code
    DXQ
    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
    DXQ Blood Pressure Cuff

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    Other Clearances by Heine Optotechnik GmbH & Co. KG

    K Number Device Name
    K142486 HEINE BETA 200, HEINE BETA 200 S, HEINE K 180
    K142837 HEINE SIGMA 250 & HEINE SIGMA 250 M2
    K131959 HEINE MINI 3000(R) OPHTHALMOSCOPE
    K131961 HEINE BETA 200(R) OPHTHALMOSCOPE
    K123587 HEINE MINI 3000 LED OPHTHALMOSCOPE
    K123316 HEINE OMEGA 500