FDA 510(k)

Aulisa 多病人數位生命徵監測系統

K 號：K202497 · 2020-10-30

申請人Taiwan Aulisa Medical Devices Technologies, Inc.

決定日期2020-10-30

產品代碼MSX

諮詢委員會履歷

決定相當於

器材摘要

Aulisa Multiple Patient 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 2020-10-30 under 510(k) number K202497. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Aulisa Multiple Patient Digital Vital Sign Monitoring System?

Aulisa Multiple Patient Digital Vital Sign Monitoring System is a medical device that received FDA 510(k) clearance on 2020-10-30. The listed applicant is Taiwan Aulisa Medical Devices Technologies, Inc.. The 510(k) number is K202497.

When did Aulisa Multiple Patient Digital Vital Sign Monitoring System receive FDA 510(k) clearance?

Aulisa Multiple Patient Digital Vital Sign Monitoring System received FDA 510(k) clearance on 2020-10-30, under 510(k) number K202497.

Who is the listed applicant for Aulisa Multiple Patient 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 Aulisa Multiple Patient Digital Vital Sign Monitoring System?

The FDA product code for Aulisa Multiple Patient Digital Vital Sign Monitoring System is MSX.

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)K203208守護天使Rx GA2000系列數位生命徵象監測系統 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

查看所有 9 項裝置 →

相關器械（代碼：MSX）

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。

K261287數位統計護理Ascom Ums Srl Unipersonale K260211儀表板（P007000）Hill-Rom, Inc.K261367柯薩諾 CardioWatch 287-2 系統Corsano Health B.V.K253654IntelliVue測量架6000（867317）Philips Medizin Systeme Böblingen GmbH K243270虎連接警報管理Tigerconnect K242728BeneVision 中央監控系統Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。