FDA 510(k)

Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor

K-Number: K172625 · 2018-05-11

Decision Date2018-05-11

Product CodeDQA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor is a medical device manufactured by Nonin Medical, Inc.. It received FDA 510(k) clearance on 2018-05-11 under approval number K172625. 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 Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor?

Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor is a medical device that received FDA 510(k) clearance on 2018-05-11. It is manufactured by Nonin Medical, Inc.. The 510(k) number is K172625.

When was Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor approved by the FDA?

Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor received FDA 510(k) clearance on 2018-05-11, under approval number K172625.

What company makes Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor?

Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor is manufactured by Nonin Medical, Inc..

What is the FDA product code for Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor?

The FDA product code for Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor is DQA.

Related Clinical Trials

NCT07615738 SpO2 Infant and Pediatric Study NOT_YET_RECRUITING NCT07608614 Sleep and Performance RECRUITING NCT07226193 Detecting Peripheral Artery Disease With the Pulse RECRUITING NCT07558291 Continuous Glucose Monitoring Versus Self-Monitoring of Blood Glucose in Women With Gestational Diabetes NOT_YET_RECRUITING NCT05690633 Feasibility of Obtaining Pulse Oximetry Readings From the Oropharynx COMPLETED NCT07552025 Detection of Respiratory Events Using Acoustic Monitoring in Extremely Preterm Infants NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41265798 Comparison of two models of biofilm formation on reusable stainless steel medical device material. The Journal of hospital infection (2026) PMID: 40498444 Assessing the Impact of End-of-Life Processing on Reusable Medical Devices. Biomedical instrumentation & technology (2025) PMID: 40487675 Antiemetic effect of acupressure wristbands for GLP-1 medication associated nausea. Obesity pillars (2025) PMID: 40006408 Improving Fall Classification Accuracy of Multi-Input Models Using Three-Axis Accelerometer and Heart Rate Variability Data. Sensors (Basel, Switzerland) (2025)

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 K191403Pulse Oximeter 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

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