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

    RARE-EARTH INTRA-OCULAR MAGNET

    K Number: K831702 · Decision Jun 30, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    4
    Applicant Total
    6
    Review Days
    36

    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
    RARE-EARTH INTRA-OCULAR MAGNET
    K Number
    K831702
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4445
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Miami Eye Technology, Inc.
    Date Received
    May 25, 1983
    Decision Date
    June 30, 1983
    Product Code
    HPN
    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
    HPN Magnet, Permanent

    Similar 510(k) Clearances

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

    EYE SEE INSTRUMENT

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    H200 HANNA SUCTION TREPHINE SYSTEM FOR CORNEAL SUR

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    PAREL RARE EARTH MAGNET, I.O.M., INTRAOCULAR MAG

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    RARE EARTH INTRA-OCULAR MAGNET

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

    Other Clearances by Miami Eye Technology, Inc.

    K Number Device Name
    K841101 CLAYMAN-PAREL CAPSULE COUPEUR
    K832912 GELENDER VACUUM FIXATION RING SYS
    K832996 SURGICAL IOP MONITOR
    K832997 EPA AUTOMATED INFUSION POLE
    K832911 ABBOTT GLOBE HOLDER