FDA 510(k)

뉴 디안트론릭스 E 그린™ 전기수술 단극 펜스

K-번호: K170161 · 2017-03-29

결정일2017-03-29

제품 코드GEI

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

결정대체적으로 동일

기기 요약

New Deantronics E Green™ Electrosurgical Monopolar Pencils is the device name listed in this FDA 510(k) record. The listed applicant is New Deantronics Taiwan , Ltd.. It received FDA 510(k) clearance on 2017-03-29 under 510(k) number K170161. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the New Deantronics E Green™ Electrosurgical Monopolar Pencils?

New Deantronics E Green™ Electrosurgical Monopolar Pencils is a medical device that received FDA 510(k) clearance on 2017-03-29. The listed applicant is New Deantronics Taiwan , Ltd.. The 510(k) number is K170161.

When did New Deantronics E Green™ Electrosurgical Monopolar Pencils receive FDA 510(k) clearance?

New Deantronics E Green™ Electrosurgical Monopolar Pencils received FDA 510(k) clearance on 2017-03-29, under 510(k) number K170161.

Who is the listed applicant for New Deantronics E Green™ Electrosurgical Monopolar Pencils?

The FDA 510(k) record lists New Deantronics Taiwan , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for New Deantronics E Green™ Electrosurgical Monopolar Pencils?

The FDA product code for New Deantronics E Green™ Electrosurgical Monopolar Pencils is GEI.

New Deantronics Taiwan , Ltd.를 신청인으로 등재한 기타 기록

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