FDA 510(k)

Andorate 조직 채취 밸브, Andorate 조직 채취 이식기

K-번호: K200481 · 2020-06-18

결정일2020-06-18

제품 코드ODC

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

Andorate Biopsy Valve, Andorate Biopsy Irrigator is the device name listed in this FDA 510(k) record. The listed applicant is Ga Health Company Limited. It received FDA 510(k) clearance on 2020-06-18 under 510(k) number K200481. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Andorate Biopsy Valve, Andorate Biopsy Irrigator?

Andorate Biopsy Valve, Andorate Biopsy Irrigator is a medical device that received FDA 510(k) clearance on 2020-06-18. The listed applicant is Ga Health Company Limited. The 510(k) number is K200481.

When did Andorate Biopsy Valve, Andorate Biopsy Irrigator receive FDA 510(k) clearance?

Andorate Biopsy Valve, Andorate Biopsy Irrigator received FDA 510(k) clearance on 2020-06-18, under 510(k) number K200481.

Who is the listed applicant for Andorate Biopsy Valve, Andorate Biopsy Irrigator?

The FDA 510(k) record lists Ga Health Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Andorate Biopsy Valve, Andorate Biopsy Irrigator?

The FDA product code for Andorate Biopsy Valve, Andorate Biopsy Irrigator is ODC.

Ga Health Company Limited를 신청인으로 등재한 기타 기록

K232118ANDORATE® 밸브 키트 K231602Protego 공기수 연결기; Protego 공기수 병 튜브; Protego 하이브리드 튜브 K230932ANDORATE® 밸브 키트 K230280ANDORATE® 수술 밸브 및 ANDORATE® 조직 생검 밸브 K223171AquaPulse® 이라이제이션 튜빙 K213095andorate Suction Valve, andorate Air/Water Valve

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