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FDA 510(k)

Finger Clip Pulse Oximeter

K-Number: K231243 · 2023-10-31

ApplicantGuangdong Genial Technology Co., Ltd.
Decision Date2023-10-31
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Finger Clip Pulse Oximeter is a medical device manufactured by Guangdong Genial Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-10-31 under approval number K231243. 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 Finger Clip Pulse Oximeter?

Finger Clip Pulse Oximeter is a medical device that received FDA 510(k) clearance on 2023-10-31. It is manufactured by Guangdong Genial Technology Co., Ltd.. The 510(k) number is K231243.

When was Finger Clip Pulse Oximeter approved by the FDA?

Finger Clip Pulse Oximeter received FDA 510(k) clearance on 2023-10-31, under approval number K231243.

What company makes Finger Clip Pulse Oximeter?

Finger Clip Pulse Oximeter is manufactured by Guangdong Genial Technology Co., Ltd..

What is the FDA product code for Finger Clip Pulse Oximeter?

The FDA product code for Finger Clip 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 NCT07226193 Detecting Peripheral Artery Disease With the Pulse RECRUITING 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

Other Devices by Guangdong Genial Technology Co., Ltd.

K231250Digital Blood Pressure Monitor K231245Digital Blood Pressure Monitor (Arm Type) K240333Wearable Digital Thermometer (T31) K232678Digital Thermometer, Model T28, T28L

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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