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

    PERSONAL TELEMEDICINE MODULE

    K Number: K964554 · Decision Dec 17, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    190
    Applicant Total
    9
    Review Days
    34

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    Basic Information

    Device Name
    PERSONAL TELEMEDICINE MODULE
    K Number
    K964554
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2910
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American Telecare, Inc.
    Date Received
    November 13, 1996
    Decision Date
    December 17, 1996
    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 American Telecare, Inc.

    K Number Device Name
    K030222 NX SYSTEM
    K003999 AVIVA SYSTEM, MODEL SL 2020; AVIVA SLX SYSTEM SYSTEM, MODEL SLX 1010
    K993550 AVIVA SYSTEM, MODEL SL1010
    K981533 AVIVA SYSTEMS MODEL NUMBERS 1010, 2020
    K973873 DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1
    K963678 CARETONE II
    K952882 PERSONAL TELEMEDICINE SYSTEM
    K945638 TELPHONIC STETHOSCOPE