FDA 510(k)

Pulse Oximeter (Model C101A2, C101B1, C101A3)

K-번호: K221979 · 2022-10-16

신청자Shenzhen Imdk Medical Technology Co., Ltd.

결정일2022-10-16

제품 코드DQA

자문 위원회CV

결정Substantially Equivalent

기기 요약

Pulse Oximeter (Model C101A2, C101B1, C101A3) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Imdk Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-10-16 under 510(k) number K221979. 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 Pulse Oximeter (Model C101A2, C101B1, C101A3)?

Pulse Oximeter (Model C101A2, C101B1, C101A3) is a medical device that received FDA 510(k) clearance on 2022-10-16. The listed applicant is Shenzhen Imdk Medical Technology Co., Ltd.. The 510(k) number is K221979.

When did Pulse Oximeter (Model C101A2, C101B1, C101A3) receive FDA 510(k) clearance?

Pulse Oximeter (Model C101A2, C101B1, C101A3) received FDA 510(k) clearance on 2022-10-16, under 510(k) number K221979.

Who is the listed applicant for Pulse Oximeter (Model C101A2, C101B1, C101A3)?

The FDA 510(k) record lists Shenzhen Imdk 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 (Model C101A2, C101B1, C101A3)?

The FDA product code for Pulse Oximeter (Model C101A2, C101B1, C101A3) is DQA.

Shenzhen Imdk Medical Technology Co., Ltd.를 신청인으로 등재한 기타 기록

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