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FDA 510(k)

Pulse Oximeter(Model OHT60,OXH78)

K-Number: K230277 · 2024-01-04

ApplicantCofoe Medical Technology Co., Ltd.
Decision Date2024-01-04
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Pulse Oximeter(Model OHT60,OXH78) is a medical device manufactured by Cofoe Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-01-04 under approval number K230277. 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(Model OHT60,OXH78)?

Pulse Oximeter(Model OHT60,OXH78) is a medical device that received FDA 510(k) clearance on 2024-01-04. It is manufactured by Cofoe Medical Technology Co., Ltd.. The 510(k) number is K230277.

When was Pulse Oximeter(Model OHT60,OXH78) approved by the FDA?

Pulse Oximeter(Model OHT60,OXH78) received FDA 510(k) clearance on 2024-01-04, under approval number K230277.

What company makes Pulse Oximeter(Model OHT60,OXH78)?

Pulse Oximeter(Model OHT60,OXH78) is manufactured by Cofoe Medical Technology Co., Ltd..

What is the FDA product code for Pulse Oximeter(Model OHT60,OXH78)?

The FDA product code for Pulse Oximeter(Model OHT60,OXH78) 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

Related Devices (Code: DQA)

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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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