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

    MEDAPPS 2.0 - REMOTE PATIENT MONITORING SYSTEM

    K Number: K124000 · Decision Jul 30, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    190
    Applicant Total
    2
    Review Days
    216

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    Basic Information

    Device Name
    MEDAPPS 2.0 - REMOTE PATIENT MONITORING SYSTEM
    K Number
    K124000
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2910
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medapps Inc., Dba Alere Connect
    Date Received
    December 26, 2012
    Decision Date
    July 30, 2013
    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 Medapps Inc., Dba Alere Connect

    K Number Device Name
    K132803 MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK