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

    AVIVA SYSTEMS MODEL NUMBERS 1010, 2020

    K Number: K981533 · Decision Jul 15, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    190
    Applicant Total
    9
    Review Days
    77

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    Basic Information

    Device Name
    AVIVA SYSTEMS MODEL NUMBERS 1010, 2020
    K Number
    K981533
    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
    April 29, 1998
    Decision Date
    July 15, 1998
    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
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    K993550 AVIVA SYSTEM, MODEL SL1010
    K973873 DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1
    K963678 CARETONE II
    K964554 PERSONAL TELEMEDICINE MODULE
    K952882 PERSONAL TELEMEDICINE SYSTEM
    K945638 TELPHONIC STETHOSCOPE