FDA 510(k)

ARVIS 수술 nawigasyon 시스템

K-번호: K203115 · 2021-07-14

결정일2021-07-14

제품 코드OLO

자문 위원회NE (이 문서는 원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.)

결정Substantially Equivalent

기기 요약

ARVIS Surgical Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Insight Medical Systems, Inc.. It received FDA 510(k) clearance on 2021-07-14 under 510(k) number K203115. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ARVIS Surgical Navigation System?

ARVIS Surgical Navigation System is a medical device that received FDA 510(k) clearance on 2021-07-14. The listed applicant is Insight Medical Systems, Inc.. The 510(k) number is K203115.

When did ARVIS Surgical Navigation System receive FDA 510(k) clearance?

ARVIS Surgical Navigation System received FDA 510(k) clearance on 2021-07-14, under 510(k) number K203115.

Who is the listed applicant for ARVIS Surgical Navigation System?

The FDA 510(k) record lists Insight Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARVIS Surgical Navigation System?

The FDA product code for ARVIS Surgical Navigation System is OLO.

Insight Medical Systems, Inc.를 신청인으로 등재한 기타 기록

K240062ARVIS® 어깨

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.