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

    Handheld Pulse Oximeter, Model SP-20

    K Number: K172792 · Decision Nov 13, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    11
    Review Days
    424

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    Basic Information

    Device Name
    Handheld Pulse Oximeter, Model SP-20
    K Number
    K172792
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Creative Industry Co., Ltd.
    Date Received
    September 15, 2017
    Decision Date
    November 13, 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 Shenzhen Creative Industry Co., Ltd.

    K Number Device Name
    K201468 Pulse Oximeter
    K192343 Patient Monitor
    K170047 All-in-One Health Monitor, PC-303
    K150093 Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1
    K123711 PATIENT MONITOR
    K120502 PC-60NW FINGERTIP OXIMETER
    K093016 VITAL SIGNS MONITOR
    K082055 MODEL PC-860 FETAL DOPPLER
    K073152 PC-180 / PRINCE 180 EASY ECG MONITOR
    K063641 PC-60, NON-INVASIVEPULSE OXIMETER
    Search all 11 clearances from Shenzhen Creative Industry Co., Ltd. →