FDA 510(k)

Pentax Medical Valve Set

K-번호: K222980 · 2022-11-21

신청자Yangzhou Fartley Medical Instrument Technology Co., Ltd.

결정일2022-11-21

제품 코드ODC

자문 위원회규제 정책: medical-regulatory-v1 GU

결정Substantially Equivalent

기기 요약

Pentax Medical Valve Set is the device name listed in this FDA 510(k) record. The listed applicant is Yangzhou Fartley Medical Instrument Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-11-21 under 510(k) number K222980. 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 Pentax Medical Valve Set?

Pentax Medical Valve Set is a medical device that received FDA 510(k) clearance on 2022-11-21. The listed applicant is Yangzhou Fartley Medical Instrument Technology Co., Ltd.. The 510(k) number is K222980.

When did Pentax Medical Valve Set receive FDA 510(k) clearance?

Pentax Medical Valve Set received FDA 510(k) clearance on 2022-11-21, under 510(k) number K222980.

Who is the listed applicant for Pentax Medical Valve Set?

The FDA 510(k) record lists Yangzhou Fartley Medical Instrument Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pentax Medical Valve Set?

The FDA product code for Pentax Medical Valve Set is ODC.

Yangzhou Fartley Medical Instrument Technology Co., Ltd.를 신청인으로 등재한 기타 기록

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