BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System

    K Number: K191207 · Decision Jun 25, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    403
    Registration Numbers
    403
    Same Product Code
    711
    Applicant Total
    8
    Review Days
    50

    Basic Information

    Device Name
    Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System
    K Number
    K191207
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Taiwan Aulisa Medical Devices Technologies, Inc.
    Date Received
    May 6, 2019
    Decision Date
    June 25, 2019
    Product Code
    DQA
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DQA Oximeter

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    Other Clearances by Taiwan Aulisa Medical Devices Technologies, Inc.

    K Number Device Name
    K233963 Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)
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    K240220 Aulisa Temperature Module (TM0002)
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    K202497 Aulisa Multiple Patient Digital Vital Sign Monitoring System
    K182822 Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System
    K183067 Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System