FDA 510(k)

CMO8成人PMP氧合器及管路包（型號：CME40009）

K 號：K231414 · 2023-11-01

決定日期2023-11-01

產品代碼DTZ

諮詢委員會履歷

決定相當於

器材摘要

CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) is the device name listed in this FDA 510(k) record. The listed applicant is Chalice Medical , Ltd.. It received FDA 510(k) clearance on 2023-11-01 under 510(k) number K231414. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)?

CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) is a medical device that received FDA 510(k) clearance on 2023-11-01. The listed applicant is Chalice Medical , Ltd.. The 510(k) number is K231414.

When did CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) receive FDA 510(k) clearance?

CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) received FDA 510(k) clearance on 2023-11-01, under 510(k) number K231414.

Who is the listed applicant for CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)?

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

What is the FDA product code for CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)?

The FDA product code for CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) is DTZ.

其他以 Chalice Medical , Ltd. 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。

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相關器械（代碼：DTZ）

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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