FDA 510(k)

膀胱 스캐너, 모델 이름: M5

K-번호: K213488 · 2022-07-01

신청자Suzhou Peaksonic Medical Technology Co., Ltd.

결정일2022-07-01

제품 코드IYO

자문 위원회[원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

Bladder Scanner, Model Name:M5 is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Peaksonic Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-07-01 under 510(k) number K213488. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Bladder Scanner, Model Name:M5?

Bladder Scanner, Model Name:M5 is a medical device that received FDA 510(k) clearance on 2022-07-01. The listed applicant is Suzhou Peaksonic Medical Technology Co., Ltd.. The 510(k) number is K213488.

When did Bladder Scanner, Model Name:M5 receive FDA 510(k) clearance?

Bladder Scanner, Model Name:M5 received FDA 510(k) clearance on 2022-07-01, under 510(k) number K213488.

Who is the listed applicant for Bladder Scanner, Model Name:M5?

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

What is the FDA product code for Bladder Scanner, Model Name:M5?

The FDA product code for Bladder Scanner, Model Name:M5 is IYO.

Suzhou Peaksonic Medical Technology Co., Ltd.를 신청인으로 등재한 기타 기록

K201316膀胱 스캐너 (모델: M3, M3-HD, M4, M4-HD)

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