FDA 510(k)

Med-Link Temp-pulse 산소饱和도 측정기

K-번호: K202743 · 2021-03-01

신청자Shenzhen Med-Link Electronics Tech Co., Ltd.

결정일2021-03-01

제품 코드DQA

자문 위원회CV

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

Shenzhen Med-Link Electronics Tech Co., Ltd.를 신청인으로 등재한 기타 기록

K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)K220448Disposable Non-invasive EEG Sensor K220447Med-link Disposable ECG Cable and Leadwires K212752Med-link Pulse Oximeter K210441Incontinence Probe K193338Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes

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