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

    PSI BANDS

    K Number: K070766 · Decision Jul 26, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    12
    Applicant Total
    1
    Review Days
    128

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    Basic Information

    Device Name
    PSI BANDS
    K Number
    K070766
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Psi Health Solutions, Inc.
    Date Received
    March 20, 2007
    Decision Date
    July 26, 2007
    Product Code
    MVV
    Advisory Committee
    Unknown
    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
    MVV Device, Acupressure

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