FDA 510(k)

守護天使 GA1000 電子生命徵象監測系統

K 號：K162580 · 2017-03-03

申請人Taiwan Aulisa Medical Devices Technologies, Inc.

決定日期2017-03-03

產品代碼DQA

諮詢委員會履歷

決定相當於

器材摘要

Guardian Angel GA1000 Digital Vital Sign Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Taiwan Aulisa Medical Devices Technologies, Inc.. It received FDA 510(k) clearance on 2017-03-03 under 510(k) number K162580. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Guardian Angel GA1000 Digital Vital Sign Monitoring System?

Guardian Angel GA1000 Digital Vital Sign Monitoring System is a medical device that received FDA 510(k) clearance on 2017-03-03. The listed applicant is Taiwan Aulisa Medical Devices Technologies, Inc.. The 510(k) number is K162580.

When did Guardian Angel GA1000 Digital Vital Sign Monitoring System receive FDA 510(k) clearance?

Guardian Angel GA1000 Digital Vital Sign Monitoring System received FDA 510(k) clearance on 2017-03-03, under 510(k) number K162580.

Who is the listed applicant for Guardian Angel GA1000 Digital Vital Sign Monitoring System?

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

What is the FDA product code for Guardian Angel GA1000 Digital Vital Sign Monitoring System?

The FDA product code for Guardian Angel GA1000 Digital Vital Sign Monitoring System is DQA.

其他以 Taiwan Aulisa Medical Devices Technologies, Inc. 為申請人之記錄

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相關器械（代碼：DQA）

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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