FDA 510(k)

ArtPIX DRF

K-번호: K202235 · 2020-09-03

결정일2020-09-03

제품 코드JAA

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

결정대체적으로 동일

기기 요약

ArtPIX DRF is the device name listed in this FDA 510(k) record. The listed applicant is Cmt Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2020-09-03 under 510(k) number K202235. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ArtPIX DRF?

ArtPIX DRF is a medical device that received FDA 510(k) clearance on 2020-09-03. The listed applicant is Cmt Medical Technologies, Ltd.. The 510(k) number is K202235.

When did ArtPIX DRF receive FDA 510(k) clearance?

ArtPIX DRF received FDA 510(k) clearance on 2020-09-03, under 510(k) number K202235.

Who is the listed applicant for ArtPIX DRF?

The FDA 510(k) record lists Cmt Medical Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ArtPIX DRF?

The FDA product code for ArtPIX DRF is JAA.

Cmt Medical Technologies, Ltd.를 신청인으로 등재한 기타 기록

K162224ArtPix Mobile EZ2GO

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