FDA 510(k)

트윈스캔 808/755 레이저 시스템

K-번호: K192269 · 2019-11-19

결정일2019-11-19

제품 코드GEX

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

결정대체적으로 동일

기기 요약

TwinScan 808/755 Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Gme German Medical Engineering GmbH. It received FDA 510(k) clearance on 2019-11-19 under 510(k) number K192269. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the TwinScan 808/755 Laser System?

TwinScan 808/755 Laser System is a medical device that received FDA 510(k) clearance on 2019-11-19. The listed applicant is Gme German Medical Engineering GmbH. The 510(k) number is K192269.

When did TwinScan 808/755 Laser System receive FDA 510(k) clearance?

TwinScan 808/755 Laser System received FDA 510(k) clearance on 2019-11-19, under 510(k) number K192269.

Who is the listed applicant for TwinScan 808/755 Laser System?

The FDA 510(k) record lists Gme German Medical Engineering GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TwinScan 808/755 Laser System?

The FDA product code for TwinScan 808/755 Laser System is GEX. This falls under the Gastroenterology category.

Gme German Medical Engineering GmbH를 신청인으로 등재한 기타 기록

K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL 라이트 308 nm, FlexSys IR 1550 nm K203054플렉스시스 K180518GME LinScan Lite 808 레이저 시스템

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