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

    Pulse Oximeter

    K Number: K191403 · Decision Dec 20, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    50
    Review Days
    210

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    Basic Information

    Device Name
    Pulse Oximeter
    K Number
    K191403
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nonin Medical, Inc.
    Date Received
    May 24, 2019
    Decision Date
    December 20, 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 Nonin Medical, Inc.

    K Number Device Name
    K211498 Nonin OTC Pulse Oximeter Model 3250
    K192900 H500 Multi-Sensing Oximetry System
    K190560 SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface
    K172625 Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor
    K160231 Model X-100C CO-Met™ Oximetry System
    K160865 Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6102C Series: 6102CA, 6102CP, 6102CI, 6102CN), Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor, Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Senso
    K151305 SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg)
    K140785 PULSE OXIMETER
    K132402 SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM
    K131021 PULSE OXIMETER
    Search all 50 clearances from Nonin Medical, Inc. →