BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PERRYMETER(TM)

    K Number: K911190 · Decision Jul 26, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    64
    Applicant Total
    1
    Review Days
    130

    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
    PERRYMETER(TM)
    K Number
    K911190
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1425
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Perrymeter Systems
    Date Received
    March 18, 1991
    Decision Date
    July 26, 1991
    Product Code
    HIR
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HIR Perineometer

    Similar 510(k) Clearances

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

    Pelvic Floor Exerciser (PF01)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Vaginal Tactile Ultrasound Imager

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Perifit Care+

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Perifit

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all