FDA 510(k)

Respiree 心肺監護儀

K 號：K223681 · 2023-03-08

決定日期2023-03-08

產品代碼BZQ

諮詢委員會AN

決定相當於

器材摘要

Respiree Cardio-Respiratory Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Respiree Pte, Ltd.. It received FDA 510(k) clearance on 2023-03-08 under 510(k) number K223681. 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 Respiree Cardio-Respiratory Monitor?

Respiree Cardio-Respiratory Monitor is a medical device that received FDA 510(k) clearance on 2023-03-08. The listed applicant is Respiree Pte, Ltd.. The 510(k) number is K223681.

When did Respiree Cardio-Respiratory Monitor receive FDA 510(k) clearance?

Respiree Cardio-Respiratory Monitor received FDA 510(k) clearance on 2023-03-08, under 510(k) number K223681.

Who is the listed applicant for Respiree Cardio-Respiratory Monitor?

The FDA 510(k) record lists Respiree Pte, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Respiree Cardio-Respiratory Monitor?

The FDA product code for Respiree Cardio-Respiratory Monitor is BZQ.

其他以 Respiree Pte, Ltd. 為申請人之記錄

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K250934Respiree 心肺監護系統

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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官方來源

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