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

    RETINA TOMOGRAPH AND FLOWMETER

    K Number: K943956 · Decision Nov 14, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    86
    Applicant Total
    9
    Review Days
    91

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    Basic Information

    Device Name
    RETINA TOMOGRAPH AND FLOWMETER
    K Number
    K943956
    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
    August 15, 1994
    Decision Date
    November 14, 1994
    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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    Other Clearances by Heidelberg Engineering

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    K042742 HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)
    K971671 HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C)
    K943955 RETINA FLOWMETER
    K944261 RETINA ANGIOGRAPH
    K912891 HEIDELBERG RETINA TOMOGRAPH