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

    NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352)

    K Number: K171822 · Decision Sep 20, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    168
    Registration Numbers
    169
    Same Product Code
    507
    Applicant Total
    2
    Review Days
    93

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    Basic Information

    Device Name
    NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352)
    K Number
    K171822
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biotest Medical Corporation
    Date Received
    June 19, 2017
    Decision Date
    September 20, 2017
    Product Code
    NBW
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NBW System, Test, Blood Glucose, Over The Counter

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    Other Clearances by Biotest Medical Corporation

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    K171785 WowGoHealth Blood Glucose Monitoring System