BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    I-SCOPE OPHTHALMIC ENDOSCOPE

    K Number: K971679 · Decision Jun 25, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    39
    Applicant Total
    9
    Review Days
    49

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    Basic Information

    Device Name
    I-SCOPE OPHTHALMIC ENDOSCOPE
    K Number
    K971679
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ophthalmic Technologies, Inc.
    Date Received
    May 7, 1997
    Decision Date
    June 25, 1997
    Product Code
    MPA
    Advisory Committee
    Gastroenterology, Urology
    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
    MPA Endoilluminator

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    Other Clearances by Ophthalmic Technologies, Inc.

    K Number Device Name
    K042885 OCT-OPTHALMOSCOPE
    K031391 HF MODULE WITH TRANSDUCERS
    K030770 OTI SCAN WITH TRANSDUCERS
    K024114 A-SCAN 100
    K990064 DI-RHEX OPHTHALMIC DIATHERMY SYSTEM
    K974522 3D I-SCAN
    K960622 I-SCAN
    K954263 XE-LITE