FDA 510(k)

D 캠에라 컨트롤러

K-번호: K211332 · 2021-10-01

신청자Richard Wolf Medical Instruments Corporation

결정일2021-10-01

제품 코드FET

자문 위원회규제 정책: medical-regulatory-v1 GU

결정Substantially Equivalent

기기 요약

D Camera Controller 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 2021-10-01 under 510(k) number K211332. 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 D Camera Controller?

D Camera Controller is a medical device that received FDA 510(k) clearance on 2021-10-01. The listed applicant is Richard Wolf Medical Instruments Corporation. The 510(k) number is K211332.

When did D Camera Controller receive FDA 510(k) clearance?

D Camera Controller received FDA 510(k) clearance on 2021-10-01, under 510(k) number K211332.

Who is the listed applicant for D Camera Controller?

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 D Camera Controller?

The FDA product code for D Camera Controller is FET.

Richard Wolf Medical Instruments Corporation를 신청인으로 등재한 기타 기록

K231291Perforated Baskets K230194HF 수술 발생기 400KHZ K212808Logic Hd camera head green, System green 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 K201897Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525 K200617Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525

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