Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Nonin Medical, Inc.

FDA 510(k) & PMA Approved Devices — 47 products

Total Devices47
Categories0
Latest FDA decision
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
510(k) K131021 PULSE OXIMETERDQA2013-09-11 View
510(k) K113215 MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGYMUD2012-05-14 View
510(k) K112843 PULSE OXIMETERDQA2012-04-19 View
510(k) K102350 PULSE OXIMETERDQA2010-12-22 View
510(k) K102715 REGIONAL OXIMETERMUD2010-12-17 View
510(k) K093853 SINGLE-PATIENT USE DISPOSABLE SENSOR SERIESDQA2010-06-04 View
510(k) K093306 SINGLE-PATIENT USE DISPOSABLE SENSORDQA2010-03-04 View
510(k) K092101 REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIESDQA2009-10-21 View
510(k) K092678 EVISION DATA MANAGEMENT SOFTWAREDQA2009-10-01 View
510(k) K090807 REGIONAL OXIMETER SYSTEM, MODEL 7600MUD2009-06-30 View
510(k) K081285 FINGER PULSE OXIMETER, MODEL 9560DQA2008-06-05 View
510(k) K080255 NONIN MEDICAL, INC., MODEL 7500 DIGITAL PULSE OXIMETERDQA2008-05-23 View
510(k) K071415 DIGITAL PULSE OXIMETER, MODEL 7500FODQA2007-08-08 View
↑