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

    PHYSIOGLOVE ES

    K Number: K050674 · Decision Apr 25, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    570
    Applicant Total
    3
    Review Days
    406

    Basic Information

    Device Name
    PHYSIOGLOVE ES
    K Number
    K050674
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    COMMWELL LTD.
    Date Received
    March 15, 2005
    Decision Date
    April 25, 2006
    Product Code
    DPS
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DPS Electrocardiograph

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    Other Clearances by COMMWELL LTD.

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