FDA 510(k)

몬테리스 메디칼 네우로블레이트 시스템

K-번호: K171255 · 2017-07-25

결정일2017-07-25

제품 코드GEX

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

결정대체적으로 동일

기기 요약

Monteris Medical NeuroBlate System is the device name listed in this FDA 510(k) record. The listed applicant is Monteris Medical, Inc.. It received FDA 510(k) clearance on 2017-07-25 under 510(k) number K171255. 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 Monteris Medical NeuroBlate System?

Monteris Medical NeuroBlate System is a medical device that received FDA 510(k) clearance on 2017-07-25. The listed applicant is Monteris Medical, Inc.. The 510(k) number is K171255.

When did Monteris Medical NeuroBlate System receive FDA 510(k) clearance?

Monteris Medical NeuroBlate System received FDA 510(k) clearance on 2017-07-25, under 510(k) number K171255.

Who is the listed applicant for Monteris Medical NeuroBlate System?

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

What is the FDA product code for Monteris Medical NeuroBlate System?

The FDA product code for Monteris Medical NeuroBlate System is GEX. This falls under the Gastroenterology category.

Monteris Medical, Inc.를 신청인으로 등재한 기타 기록

K201056뇌블레이 시스템 K162762뇌블레이 시스템

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