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

    AVIVA SYSTEM, MODEL SL 2020; AVIVA SLX SYSTEM SYSTEM, MODEL SLX 1010

    K Number: K003999 · Decision Jun 28, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    305
    Applicant Total
    9
    Review Days
    184

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    Basic Information

    Device Name
    AVIVA SYSTEM, MODEL SL 2020; AVIVA SLX SYSTEM SYSTEM, MODEL SLX 1010
    K Number
    K003999
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American Telecare, Inc.
    Date Received
    December 26, 2000
    Decision Date
    June 28, 2001
    Product Code
    MWI
    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
    MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

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    Other Clearances by American Telecare, Inc.

    K Number Device Name
    K030222 NX SYSTEM
    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
    K952882 PERSONAL TELEMEDICINE SYSTEM
    K945638 TELPHONIC STETHOSCOPE