FDA 510(k)

엔도캠 플렉스 HD 캠에라 시스템 5521

K-번호: K161204 · 2017-01-11

신청자Richard Wolf Medical Instruments Corporation

결정일2017-01-11

제품 코드FET

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

ENDOCAM Flex HD Camera System 5521 is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corporation. It received FDA 510(k) clearance on 2017-01-11 under 510(k) number K161204. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ENDOCAM Flex HD Camera System 5521?

ENDOCAM Flex HD Camera System 5521 is a medical device that received FDA 510(k) clearance on 2017-01-11. The listed applicant is Richard Wolf Medical Instruments Corporation. The 510(k) number is K161204.

When did ENDOCAM Flex HD Camera System 5521 receive FDA 510(k) clearance?

ENDOCAM Flex HD Camera System 5521 received FDA 510(k) clearance on 2017-01-11, under 510(k) number K161204.

Who is the listed applicant for ENDOCAM Flex HD Camera System 5521?

The FDA 510(k) record lists Richard Wolf Medical Instruments Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOCAM Flex HD Camera System 5521?

The FDA product code for ENDOCAM Flex HD Camera System 5521 is FET.

Richard Wolf Medical Instruments Corporation를 신청인으로 등재한 기타 기록

K231291공穿孔 바스켓 K230194HF 수술 발생기 400KHZ K212808로직 Hd 카메라 헤드 그린, 시스템 그린 K211332D 캠에라 컨트롤러 K203226TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MM K201897센서-우레테로렌스코프 9 FR WL 600 MM (단축 RIWO D-URS), 컨트롤러 5525 어댑터

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