FDA 510(k)

Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D

Número K: K151287 · 2016-01-06

RequerenteGuangdong Biolight Meditech Co., Ltd.

Data da decisão2016-01-06

Código do produtoDQA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Biolight Meditech Co., Ltd.. It received FDA 510(k) clearance on 2016-01-06 under 510(k) number K151287. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D?

Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D is a medical device that received FDA 510(k) clearance on 2016-01-06. The listed applicant is Guangdong Biolight Meditech Co., Ltd.. The 510(k) number is K151287.

When did Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D receive FDA 510(k) clearance?

Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D received FDA 510(k) clearance on 2016-01-06, under 510(k) number K151287.

Who is the listed applicant for Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D?

The FDA 510(k) record lists Guangdong Biolight Meditech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D?

The FDA product code for Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D is DQA.

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Fonte oficial

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