BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Pulse Oximeter

    K Number: K171241 · Decision Mar 27, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    6
    Review Days
    334

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    Basic Information

    Device Name
    Pulse Oximeter
    K Number
    K171241
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hunan Accurate Bio-Medical Technology Co., Ltd.
    Date Received
    April 27, 2017
    Decision Date
    March 27, 2018
    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 Hunan Accurate Bio-Medical Technology Co., Ltd.

    K Number Device Name
    K252601 Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L)
    K252748 Pelvic Floor Exerciser (PF01)
    K243049 Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)
    K240808 Pulse Oximeter (WS20A)
    K141105 PULSE OXIMETER