FDA 510(k)

308nm 엡시머 시스템

K-번호: K192642 · 2020-05-13

신청자Chongqing Peninsula Medical Technology Co., Ltd.

결정일2020-05-13

제품 코드FTC

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

결정대체적으로 동일

기기 요약

308nm Excimer System is the device name listed in this FDA 510(k) record. The listed applicant is Chongqing Peninsula Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-05-13 under 510(k) number K192642. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the 308nm Excimer System?

308nm Excimer System is a medical device that received FDA 510(k) clearance on 2020-05-13. The listed applicant is Chongqing Peninsula Medical Technology Co., Ltd.. The 510(k) number is K192642.

When did 308nm Excimer System receive FDA 510(k) clearance?

308nm Excimer System received FDA 510(k) clearance on 2020-05-13, under 510(k) number K192642.

Who is the listed applicant for 308nm Excimer System?

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

What is the FDA product code for 308nm Excimer System?

The FDA product code for 308nm Excimer System is FTC.

Chongqing Peninsula Medical Technology Co., Ltd.를 신청인으로 등재한 기타 기록

K192552이온화 미용 장비 K172273308nm 엡시머 시스템 K171835이온화 미용 장비

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