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FDA 510(k)

心脈血氧濃度計（FRO-200、FRO-201、FRO-202、FRO-203、FRO-204、FRO-100、FRO-101、FRO-102、FRO-103、FRO-104）

K 號：K211632 · 2022-01-14

申請人Shenzhen Narig Bio-Medical Technology Co., Ltd.
決定日期2022-01-14
產品代碼DQA
諮詢委員會履歷
決定相當於

器材摘要

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.

常見問題

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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