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Nonin Medical, Inc.

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories3
Latest FDA decision2024-11-13
TypeNumberDevice NameCodeDateActions
510(k) K211498 Nonin OTC Pulse Oximeter Model 3250OLK2024-11-13 View
510(k) K192900 H500 Multi-Sensing Oximetry SystemDQA2020-06-29 View
510(k) K191403 Pulse OximeterDQA2019-12-20 View
510(k) K190560 SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient InterfaceMUD2019-05-02 View
510(k) K172625 Reusable, Finger Clip Nonin Medical CO-Met Oximetry SensorDQA2018-05-11 View
510(k) K160231 Model X-100C CO-Met™ Oximetry SystemDQA2016-12-23 View
510(k) 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 SensoDQA2016-08-05 View
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