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

    AGAR 3K NEUROMUSCULAR STIMULATOR

    K Number: K882386 · Decision Oct 18, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    7
    Review Days
    495

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    Basic Information

    Device Name
    AGAR 3K NEUROMUSCULAR STIMULATOR
    K Number
    K882386
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Solcoor, Inc.
    Date Received
    June 10, 1988
    Decision Date
    October 18, 1989
    Product Code
    IPF
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IPF Stimulator, Muscle, Powered

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    Other Clearances by Solcoor, Inc.

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    K861896 UNI-TENS XL TENS
    K861894 AGAR 9K TENS
    K851265 PEAK FLOWMETERS FOR SPIROMETRY