FDA 510(k)

Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)

Número K: K211632 · 2022-01-14

RequerenteShenzhen Narig Bio-Medical Technology Co., Ltd.

Data da decisão2022-01-14

Código do produtoDQA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Narig Bio-Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-01-14 under 510(k) number K211632. 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 Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)?

Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104) is a medical device that received FDA 510(k) clearance on 2022-01-14. The listed applicant is Shenzhen Narig Bio-Medical Technology Co., Ltd.. The 510(k) number is K211632.

When did Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104) receive FDA 510(k) clearance?

Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104) received FDA 510(k) clearance on 2022-01-14, under 510(k) number K211632.

Who is the listed applicant for Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)?

The FDA 510(k) record lists Shenzhen Narig Bio-Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)?

The FDA product code for Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104) is DQA.

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