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

    MODEL 200 SQUID

    K Number: K822853 · Decision Oct 18, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    67
    Same Product Code
    40
    Applicant Total
    8
    Review Days
    21

    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
    MODEL 200 SQUID
    K Number
    K822853
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1605
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Synemed, Inc.
    Date Received
    September 27, 1982
    Decision Date
    October 18, 1982
    Product Code
    HPT
    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
    HPT Perimeter, Automatic, Ac-Powered

    Similar 510(k) Clearances

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

    MAIA, MODEL 1

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    FORESEE HOME

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    TRUEFIELD ANALYZER

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP)

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    NOVAVISION, MODEL 2.0

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

    Other Clearances by Synemed, Inc.

    K Number Device Name
    K954037 FIELD TREND
    K852936 THE FIELDMASTER MODEL 275
    K833274 DERMATOLOGY HANDPIECE-OPHTH LASER
    K831085 SYNEVAC VACUUM SOURCE UNIT
    K828585 OPTHALAS PHOTOCOAGULATOR
    K813282 SYNEVAC VACUUM CURETTAGE SYSTEMS
    K811270 SCOPE MASTER