FDA 510(k)

극대화 미니너딩 장치

K-번호: K182407 · 2019-07-19

결정일2019-07-19

제품 코드QAI

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

결정대체적으로 동일

기기 요약

Exceed Microneedling device is the device name listed in this FDA 510(k) record. The listed applicant is Mt. Derm GmbH. It received FDA 510(k) clearance on 2019-07-19 under 510(k) number K182407. The device is classified under product code QAI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Exceed Microneedling device?

Exceed Microneedling device is a medical device that received FDA 510(k) clearance on 2019-07-19. The listed applicant is Mt. Derm GmbH. The 510(k) number is K182407.

When did Exceed Microneedling device receive FDA 510(k) clearance?

Exceed Microneedling device received FDA 510(k) clearance on 2019-07-19, under 510(k) number K182407.

Who is the listed applicant for Exceed Microneedling device?

The FDA 510(k) record lists Mt. Derm GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Exceed Microneedling device?

The FDA product code for Exceed Microneedling device is QAI.

Mt. Derm GmbH를 신청인으로 등재한 기타 기록

K233709제한없는 Exceed K180778초과 마이크로니들링 장치

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