FDA 510(k)

EarlySense Insight 시스템

K-번호: K152911 · 2016-05-06

결정일2016-05-06

제품 코드BZQ

자문 위원회안내: 의료기기 규제 문서 번역 요청입니다. 회사명, 제품명, FDA, 510(k), PMA, NCT, PMID, 식별자 및 URL을 보존하여 번역하여 주세요. 정책: 의료규제-v1. [원문] AN [번역] 안내

결정Substantially Equivalent

기기 요약

EarlySense Insight Sytem is the device name listed in this FDA 510(k) record. The listed applicant is Earlysense, Ltd.. It received FDA 510(k) clearance on 2016-05-06 under 510(k) number K152911. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the EarlySense Insight Sytem?

EarlySense Insight Sytem is a medical device that received FDA 510(k) clearance on 2016-05-06. The listed applicant is Earlysense, Ltd.. The 510(k) number is K152911.

When did EarlySense Insight Sytem receive FDA 510(k) clearance?

EarlySense Insight Sytem received FDA 510(k) clearance on 2016-05-06, under 510(k) number K152911.

Who is the listed applicant for EarlySense Insight Sytem?

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

What is the FDA product code for EarlySense Insight Sytem?

The FDA product code for EarlySense Insight Sytem is BZQ.

Earlysense, Ltd.를 신청인으로 등재한 기타 기록

K171836EarlySense 침대 감지 단위

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