BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MAGNI-CAM

    K Number: K920069 · Decision Mar 2, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    55

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MAGNI-CAM
    K Number
    K920069
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5820
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Innoventions, Inc.
    Date Received
    January 7, 1992
    Decision Date
    March 2, 1992
    Product Code
    HJG
    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
    HJG System, Reading, Television, Closed-Circuit

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HJG), ordered by most recent decision date.

    LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MENTOR HORIZON LOW VISION MAGNIFIER

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MAGNILINK SYSTEM 602

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MAGNILINK SYSTEM 402/5

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MAGNILINK SYSTEM 209

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MAGNILINK SYSTEM 101

    FDA 510(k)
    FDA Class 1 ·Ophthalmic
    View all