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FDA 510(k)

Atrauman® Ag

K 號:K242758 · 2024-12-09

決定日期2024-12-09
產品代碼FRO
決定相當於

器材摘要

Atrauman® Ag is the device name listed in this FDA 510(k) record. The listed applicant is Hartmann USA, Inc.. It received FDA 510(k) clearance on 2024-12-09 under 510(k) number K242758. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the Atrauman® Ag?

Atrauman® Ag is a medical device that received FDA 510(k) clearance on 2024-12-09. The listed applicant is Hartmann USA, Inc.. The 510(k) number is K242758.

When did Atrauman® Ag receive FDA 510(k) clearance?

Atrauman® Ag received FDA 510(k) clearance on 2024-12-09, under 510(k) number K242758.

Who is the listed applicant for Atrauman® Ag?

The FDA 510(k) record lists Hartmann USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Atrauman® Ag?

The FDA product code for Atrauman® Ag is FRO. This falls under the Anesthesiology category.

相關臨床試驗

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相關器械(代碼:FRO)

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。

官方來源

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