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

    STELLAR MODEL HS-04

    K Number: K973223 · Decision Feb 18, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    1
    Review Days
    175

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    Basic Information

    Device Name
    STELLAR MODEL HS-04
    K Number
    K973223
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stellar Medical Corp.
    Date Received
    August 27, 1997
    Decision Date
    February 18, 1998
    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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