FDA 510(k)

早期感知床監測單位

K 號：K171836 · 2018-01-04

決定日期2018-01-04

產品代碼BZQ

諮詢委員會AN

決定相當於

器材摘要

EarlySense Bed Sensing Unit is the device name listed in this FDA 510(k) record. The listed applicant is Earlysense, Ltd.. It received FDA 510(k) clearance on 2018-01-04 under 510(k) number K171836. 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 Bed Sensing Unit?

EarlySense Bed Sensing Unit is a medical device that received FDA 510(k) clearance on 2018-01-04. The listed applicant is Earlysense, Ltd.. The 510(k) number is K171836.

When did EarlySense Bed Sensing Unit receive FDA 510(k) clearance?

EarlySense Bed Sensing Unit received FDA 510(k) clearance on 2018-01-04, under 510(k) number K171836.

Who is the listed applicant for EarlySense Bed Sensing Unit?

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 Bed Sensing Unit?

The FDA product code for EarlySense Bed Sensing Unit is BZQ.

其他以 Earlysense, Ltd. 為申請人之記錄

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K152911早期感知系統

相關器械（代碼：BZQ）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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