FDA 510(k)

早期感知系統

K 號：K152911 · 2016-05-06

決定日期2016-05-06

產品代碼BZQ

諮詢委員會AN

決定相當於

器材摘要

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.

常見問題

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.

其他以 Earlysense, Ltd. 為申請人之記錄

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K171836早期感知床監測單位

相關器械（代碼：BZQ）

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