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FDA 510(k)

Med-Link Temp-pulse Oximeter

K-Number: K202743 · 2021-03-01

ApplicantShenzhen Med-Link Electronics Tech Co., Ltd.
Decision Date2021-03-01
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Med-Link Temp-pulse Oximeter is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Med-Link Electronics Tech Co., Ltd.. It received FDA 510(k) clearance on 2021-03-01 under 510(k) number K202743. 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 Temp-pulse Oximeter?

Med-Link Temp-pulse Oximeter is a medical device that received FDA 510(k) clearance on 2021-03-01. The listed applicant is Shenzhen Med-Link Electronics Tech Co., Ltd.. The 510(k) number is K202743.

When did Med-Link Temp-pulse Oximeter receive FDA 510(k) clearance?

Med-Link Temp-pulse Oximeter received FDA 510(k) clearance on 2021-03-01, under 510(k) number K202743.

Who is the listed applicant for Med-Link Temp-pulse Oximeter?

The FDA 510(k) record lists Shenzhen Med-Link Electronics Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Med-Link Temp-pulse Oximeter?

The FDA product code for Med-Link Temp-pulse Oximeter is DQA.

Other records listing Shenzhen Med-Link Electronics Tech Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)K220448Disposable Non-invasive EEG SensorK220447Med-link Disposable ECG Cable and LeadwiresK212752Med-link Pulse OximeterK210441Incontinence ProbeK193338Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes

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Related Devices (Code: DQA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbHK252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin SystemeK260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita CorporationK252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply 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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