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

    HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C)

    K Number: K971671 · Decision Jul 29, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    86
    Applicant Total
    9
    Review Days
    83

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    Basic Information

    Device Name
    HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C)
    K Number
    K971671
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1570
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Heidelberg Engineering
    Date Received
    May 7, 1997
    Decision Date
    July 29, 1997
    Product Code
    HLI
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HLI Ophthalmoscope, Ac-Powered

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    K042742 HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)
    K943956 RETINA TOMOGRAPH AND FLOWMETER
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