FDA 510(k)

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K-번호: K171130 · 2017-05-04

결정일2017-05-04

제품 코드LLZ

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

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기기 요약

Nucleus Image Management System is the device name listed in this FDA 510(k) record. The listed applicant is Nucleushealth, LLC. It received FDA 510(k) clearance on 2017-05-04 under 510(k) number K171130. 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 Nucleus Image Management System?

Nucleus Image Management System is a medical device that received FDA 510(k) clearance on 2017-05-04. The listed applicant is Nucleushealth, LLC. The 510(k) number is K171130.

When did Nucleus Image Management System receive FDA 510(k) clearance?

Nucleus Image Management System received FDA 510(k) clearance on 2017-05-04, under 510(k) number K171130.

Who is the listed applicant for Nucleus Image Management System?

The FDA 510(k) record lists Nucleushealth, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nucleus Image Management System?

The FDA product code for Nucleus Image Management System is LLZ.

Nucleushealth, LLC를 신청인으로 등재한 기타 기록

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