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FDA 510(k)

Wrist Pulse Oximeter

K-Number: K152089 · 2016-08-17

ApplicantJiangsu Konsung Bio-Medical Science & Technology Co., Ltd.
Decision Date2016-08-17
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Wrist Pulse Oximeter is a medical device manufactured by Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-08-17 under approval number K152089. 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 Wrist Pulse Oximeter?

Wrist Pulse Oximeter is a medical device that received FDA 510(k) clearance on 2016-08-17. It is manufactured by Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd.. The 510(k) number is K152089.

When was Wrist Pulse Oximeter approved by the FDA?

Wrist Pulse Oximeter received FDA 510(k) clearance on 2016-08-17, under approval number K152089.

What company makes Wrist Pulse Oximeter?

Wrist Pulse Oximeter is manufactured by Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd..

What is the FDA product code for Wrist Pulse Oximeter?

The FDA product code for Wrist Pulse Oximeter is DQA.

Related Clinical Trials

NCT07260890 Paired Comparison of SVV and PVI Accuracy COMPLETED NCT06940752 VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters ENROLLING_BY_INVITATION 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

Related PubMed Literature

PMID: 39670276 Multicenter Evaluation of Machine-Learning Continuous Pulse Rate Algorithm on Wrist-Worn Device. Digital biomarkers (2024)

Other Devices by Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd.

K152091Fingertip Pulse Oximeter

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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