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

FDA 510(k)

Pulse Oximeter

K-Number: K191403 · 2019-12-20

ApplicantNonin Medical, Inc.
Decision Date2019-12-20
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Pulse Oximeter is a medical device manufactured by Nonin Medical, Inc.. It received FDA 510(k) clearance on 2019-12-20 under approval number K191403. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pulse Oximeter?

Pulse Oximeter is a medical device that received FDA 510(k) clearance on 2019-12-20. It is manufactured by Nonin Medical, Inc.. The 510(k) number is K191403.

When was Pulse Oximeter approved by the FDA?

Pulse Oximeter received FDA 510(k) clearance on 2019-12-20, under approval number K191403.

What company makes Pulse Oximeter?

Pulse Oximeter is manufactured by Nonin Medical, Inc..

What is the FDA product code for Pulse Oximeter?

The FDA product code for Pulse Oximeter is DQA.

Related Clinical Trials

NCT07260890 Paired Comparison of SVV and PVI Accuracy COMPLETED NCT04121923 Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea COMPLETED NCT05914324 Outpatient Pediatric Pulse Oximeters in Africa ACTIVE_NOT_RECRUITING NCT05690633 Feasibility of Obtaining Pulse Oximetry Readings From the Oropharynx COMPLETED NCT07527000 SpO2 Validation Study - All.Health Algo Oximeter Software COMPLETED NCT07510451 The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic Surgery RECRUITING

Other Devices by Nonin Medical, Inc.

K160231Model X-100C CO-Met™ Oximetry System K160865Model 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 K172625Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor K190560SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface K192900H500 Multi-Sensing Oximetry System K211498Nonin OTC Pulse Oximeter Model 3250

View all 7 devices →

Related Devices (Code: DQA)

K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation K160231Model X-100C CO-Met™ Oximetry SystemNonin Medical, Inc. K160940Masimo Disposable Transflectance Forehead SensorMasimo Corporation K153021Fingertip Pulse Oximeter A310Amemo, Inc. K160268Fingertip Pulse Oximeter MD300CG11/MD300CG51Beijing Choice Electronic Technology Co., Ltd. K161560Fingertip Pulse Oximeter MD300CN310Beijing Choice Electronic Technology Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑