FDA 510(k)

Aulisa 氧氣濃度模組 (第2代) (GA-OM0007, GA-OM0008)

K 號：K233963 · 2025-02-25

申請人Taiwan Aulisa Medical Devices Technologies, Inc.

決定日期2025-02-25

產品代碼DQA

諮詢委員會履歷

決定相當於

器材摘要

Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) 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 2025-02-25 under 510(k) number K233963. 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 Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)?

Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) is a medical device that received FDA 510(k) clearance on 2025-02-25. The listed applicant is Taiwan Aulisa Medical Devices Technologies, Inc.. The 510(k) number is K233963.

When did Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) receive FDA 510(k) clearance?

Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) received FDA 510(k) clearance on 2025-02-25, under 510(k) number K233963.

Who is the listed applicant for Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)?

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 Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)?

The FDA product code for Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) 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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