FDA 510(k)

변경의료 기업 뷰어

K-번호: K181185 · 2018-08-29

결정일2018-08-29

제품 코드LLZ

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

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기기 요약

Change Healthcare Enterprise Viewer is the device name listed in this FDA 510(k) record. The listed applicant is Change Healthcare Canada Company. It received FDA 510(k) clearance on 2018-08-29 under 510(k) number K181185. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Change Healthcare Enterprise Viewer?

Change Healthcare Enterprise Viewer is a medical device that received FDA 510(k) clearance on 2018-08-29. The listed applicant is Change Healthcare Canada Company. The 510(k) number is K181185.

When did Change Healthcare Enterprise Viewer receive FDA 510(k) clearance?

Change Healthcare Enterprise Viewer received FDA 510(k) clearance on 2018-08-29, under 510(k) number K181185.

Who is the listed applicant for Change Healthcare Enterprise Viewer?

The FDA 510(k) record lists Change Healthcare Canada Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Change Healthcare Enterprise Viewer?

The FDA product code for Change Healthcare Enterprise Viewer is LLZ.

Change Healthcare Canada Company를 신청인으로 등재한 기타 기록

K241981케인헬스케어 스트라투스 이미징 PACS K210719Change Healthcare 생리적 AI

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