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

    TE ME NA POLYSTIM NERVE STIMILATOR

    K Number: K990323 · Decision Sep 28, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    62
    Applicant Total
    5
    Review Days
    969

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    Basic Information

    Device Name
    TE ME NA POLYSTIM NERVE STIMILATOR
    K Number
    K990323
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2775
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Te ME NA S.A.R.L.
    Date Received
    February 2, 1999
    Decision Date
    September 28, 2001
    Product Code
    BXN
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BXN Stimulator, Nerve, Battery-Powered

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    Other Clearances by Te ME NA S.A.R.L.

    K Number Device Name
    K002405 SPINAL EPIDURAL NEEDLES
    K991259 TE ME NA EPIDURAL CATHETER
    K990100 POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE
    K990020 TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC