FDA 510(k)

피르캠 SBC 캡슐 내시 시스템, 피르캠 데스크톱 소프트웨어 9.0

K-번호: K170210 · 2017-09-01

결정일2017-09-01

제품 코드NEZ

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 is the device name listed in this FDA 510(k) record. The listed applicant is Given Imaging , Ltd.. It received FDA 510(k) clearance on 2017-09-01 under 510(k) number K170210. The device is classified under product code NEZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0?

PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 is a medical device that received FDA 510(k) clearance on 2017-09-01. The listed applicant is Given Imaging , Ltd.. The 510(k) number is K170210.

When did PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 receive FDA 510(k) clearance?

PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 received FDA 510(k) clearance on 2017-09-01, under 510(k) number K170210.

Who is the listed applicant for PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0?

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

What is the FDA product code for PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0?

The FDA product code for PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 is NEZ.

Given Imaging , Ltd.를 신청인으로 등재한 기타 기록

K180171피르카م 패턴시스템 K170839RAPID 웹 K151086만오스캔 시스템 K153466피르캠 코lon 2 캡슐 엔도스코피 시스템

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