FDA 510(k)

AutoChamber

K 號：K240786 · 2024-10-10

決定日期2024-10-10

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

AutoChamber is the device name listed in this FDA 510(k) record. The listed applicant is HeartLung Corporation. It received FDA 510(k) clearance on 2024-10-10 under 510(k) number K240786. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AutoChamber?

AutoChamber is a medical device that received FDA 510(k) clearance on 2024-10-10. The listed applicant is HeartLung Corporation. The 510(k) number is K240786.

When did AutoChamber receive FDA 510(k) clearance?

AutoChamber received FDA 510(k) clearance on 2024-10-10, under 510(k) number K240786.

Who is the listed applicant for AutoChamber?

The FDA 510(k) record lists HeartLung Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AutoChamber?

The FDA product code for AutoChamber is QIH.

其他以 HeartLung Corporation 為申請人之記錄

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相關器械（代碼：QIH）

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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