FDA 510(k)

ACCENTO / HWA Dual/Single 레이저

K-번호: K160227 · 2016-04-22

결정일2016-04-22

제품 코드GEX

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

결정대체적으로 동일

기기 요약

ACCENTO / HWA Dual/Single laser is the device name listed in this FDA 510(k) record. The listed applicant is Bison Medical Co, Ltd.. It received FDA 510(k) clearance on 2016-04-22 under 510(k) number K160227. 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 ACCENTO / HWA Dual/Single laser?

ACCENTO / HWA Dual/Single laser is a medical device that received FDA 510(k) clearance on 2016-04-22. The listed applicant is Bison Medical Co, Ltd.. The 510(k) number is K160227.

When did ACCENTO / HWA Dual/Single laser receive FDA 510(k) clearance?

ACCENTO / HWA Dual/Single laser received FDA 510(k) clearance on 2016-04-22, under 510(k) number K160227.

Who is the listed applicant for ACCENTO / HWA Dual/Single laser?

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

What is the FDA product code for ACCENTO / HWA Dual/Single laser?

The FDA product code for ACCENTO / HWA Dual/Single laser is GEX. This falls under the Gastroenterology category.

Bison Medical Co, Ltd.를 신청인으로 등재한 기타 기록

K161670Lucid Q-PTP / HWA 55

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