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

    CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B

    K Number: K073038 · Decision Jan 11, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    190
    Applicant Total
    5
    Review Days
    74

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    Basic Information

    Device Name
    CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B
    K Number
    K073038
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2910
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carematix, Inc.
    Date Received
    October 29, 2007
    Decision Date
    January 11, 2008
    Product Code
    DRG
    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
    DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

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    Other Clearances by Carematix, Inc.

    K Number Device Name
    K123020 BLIP MODEL BP-700WF
    K100508 CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B
    K040966 MODIFICATION TO CAREMATIX WELLNESS SYSTEM
    K031840 CAREMATIX WELLNESS SYSTEM