FDA 510(k)

守護天使Rx GA2000系列數位生命徵象監測系統

K 號：K203208 · 2022-06-12

申請人Taiwan Aulisa Medical Devices Technologies, Inc.

決定日期2022-06-12

產品代碼DQA

諮詢委員會履歷

決定相當於

器材摘要

Guardian Angel Rx GA2000 Series 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 2022-06-12 under 510(k) number K203208. 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 Rx GA2000 Series Digital Vital Sign Monitoring System?

Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System is a medical device that received FDA 510(k) clearance on 2022-06-12. The listed applicant is Taiwan Aulisa Medical Devices Technologies, Inc.. The 510(k) number is K203208.

When did Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System receive FDA 510(k) clearance?

Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System received FDA 510(k) clearance on 2022-06-12, under 510(k) number K203208.

Who is the listed applicant for Guardian Angel Rx GA2000 Series 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 Rx GA2000 Series Digital Vital Sign Monitoring System?

The FDA product code for Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System is DQA.

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

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。

K233963Aulisa 氧氣濃度模組 (第2代) (GA-OM0007, GA-OM0008)K233956Aulisa 幼兒氧氣濃度模組 (第2代) (GA-OM0018)K240220Aulisa 體溫模組 (TM0002)K202497Aulisa 多病人數位生命徵監測系統 K191207守護天使Rx GA2001數位生命徵象監測系統 K183067守護天使Rx GA2000數位生命徵象監測系統

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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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