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FDA 510(k)

Med-link Pulse Oximeter

K-Number: K212752 · 2022-05-20

ApplicantShenzhen Med-Link Electronics Tech Co., Ltd.
Decision Date2022-05-20
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Med-link Pulse Oximeter is a medical device manufactured by Shenzhen Med-Link Electronics Tech Co., Ltd.. It received FDA 510(k) clearance on 2022-05-20 under approval number K212752. 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 Med-link Pulse Oximeter?

Med-link Pulse Oximeter is a medical device that received FDA 510(k) clearance on 2022-05-20. It is manufactured by Shenzhen Med-Link Electronics Tech Co., Ltd.. The 510(k) number is K212752.

When was Med-link Pulse Oximeter approved by the FDA?

Med-link Pulse Oximeter received FDA 510(k) clearance on 2022-05-20, under approval number K212752.

What company makes Med-link Pulse Oximeter?

Med-link Pulse Oximeter is manufactured by Shenzhen Med-Link Electronics Tech Co., Ltd..

What is the FDA product code for Med-link Pulse Oximeter?

The FDA product code for Med-link 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 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

Other Devices by Shenzhen Med-Link Electronics Tech Co., Ltd.

K160530Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff K173869Med-link Reusable Blood Pressure Cuff K181154Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor K182667Med-link Temperature Probes K193338Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes K210441Incontinence Probe

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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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