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

    RESPERATE; MODEL RR-150

    K Number: K020399 · Decision Jul 2, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    171
    Applicant Total
    2
    Review Days
    146

    Basic Information

    Device Name
    RESPERATE; MODEL RR-150
    K Number
    K020399
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5050
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    INTERCURE LTD.
    Date Received
    February 6, 2002
    Decision Date
    July 2, 2002
    Product Code
    HCC
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HCC Device, Biofeedback

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    Other Clearances by INTERCURE LTD.

    K Number Device Name
    K000405 INTERCURE LTD. RESPI-LOW