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

    ARTHROPHONOMETER

    K Number: K862286 · Decision Jan 7, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    3
    Applicant Total
    17
    Review Days
    205

    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
    ARTHROPHONOMETER
    K Number
    K862286
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.2050
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Arthrotek, Inc.
    Date Received
    June 16, 1986
    Decision Date
    January 7, 1987
    Product Code
    NFQ
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NFQ Device, Dental Sonography, For Monitoring Jaw Sounds

    Similar 510(k) Clearances

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

    ESG-1 ELECTROSONOGRAM (ESG-1)

    FDA 510(k)
    FDA Class 1 ·Dental

    SONOPAK/QS, SONOPAK

    FDA 510(k)
    FDA Class 1 ·Dental

    ELECTROSONOGRAM ESG-1

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

    Other Clearances by Arthrotek, Inc.

    K Number Device Name
    K061776 ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE
    K061801 2.8 & 3.5MM LACTOSCREW SUTURE ANCHORS
    K061657 HITCH LACTOSORB SUTURE ANCHOR
    K061389 ALLTHREAD LACTOSORB SUTURE ANCHOR
    K060693 MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR
    K053461 EZLOC FEMORAL FIXATION DEVICE
    K051069 NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER
    K042460 TI - SCREW ANCHOR SP
    K041274 RESORBABLE INTERFERENCE SCREW
    K041261 FEMORAL HOOK
    Search all 17 clearances from Arthrotek, Inc. →