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

    PERSONAL TELEMEDICINE SYSTEM

    K Number: K952882 · Decision Sep 9, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    9
    Review Days
    444

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    Basic Information

    Device Name
    PERSONAL TELEMEDICINE SYSTEM
    K Number
    K952882
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American Telecare, Inc.
    Date Received
    June 23, 1995
    Decision Date
    September 9, 1996
    Product Code
    DXN
    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
    DXN System, Measurement, Blood-Pressure, Non-Invasive

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    Other Clearances by American Telecare, Inc.

    K Number Device Name
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    K993550 AVIVA SYSTEM, MODEL SL1010
    K981533 AVIVA SYSTEMS MODEL NUMBERS 1010, 2020
    K973873 DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1
    K963678 CARETONE II
    K964554 PERSONAL TELEMEDICINE MODULE
    K945638 TELPHONIC STETHOSCOPE