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FDA 510(k)

H500 Multi-Sensing Oximetry System

K-Number: K192900 · 2020-06-29

ApplicantNonin Medical, Inc.
Decision Date2020-06-29
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

H500 Multi-Sensing Oximetry System is a medical device manufactured by Nonin Medical, Inc.. It received FDA 510(k) clearance on 2020-06-29 under approval number K192900. 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 H500 Multi-Sensing Oximetry System?

H500 Multi-Sensing Oximetry System is a medical device that received FDA 510(k) clearance on 2020-06-29. It is manufactured by Nonin Medical, Inc.. The 510(k) number is K192900.

When was H500 Multi-Sensing Oximetry System approved by the FDA?

H500 Multi-Sensing Oximetry System received FDA 510(k) clearance on 2020-06-29, under approval number K192900.

What company makes H500 Multi-Sensing Oximetry System?

H500 Multi-Sensing Oximetry System is manufactured by Nonin Medical, Inc..

What is the FDA product code for H500 Multi-Sensing Oximetry System?

The FDA product code for H500 Multi-Sensing Oximetry System is DQA.

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Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026)

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 K191403Pulse Oximeter K190560SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface 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.

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