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

    OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P

    K Number: K092549 · Decision Nov 16, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    403
    Registration Numbers
    403
    Same Product Code
    711
    Applicant Total
    2
    Review Days
    89

    Basic Information

    Device Name
    OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P
    K Number
    K092549
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BIO MEDICAL TECHNOLOGIES CO., LTD
    Date Received
    August 19, 2009
    Decision Date
    November 16, 2009
    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 BIO MEDICAL TECHNOLOGIES CO., LTD

    K Number Device Name
    K132516 OXIPROBE E (OXIPROBE)