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FDA 510(k)

堅固式氧氣生成器 (ROG) (RO01-00001)

K 號:K240561 · 2024-12-06

決定日期2024-12-06
產品代碼CAW
諮詢委員會AN
決定相當於

器材摘要

Rugged Oxygen Generator (ROG) (RO01-00001) is the device name listed in this FDA 510(k) record. The listed applicant is Molecular Products , Ltd.. It received FDA 510(k) clearance on 2024-12-06 under 510(k) number K240561. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Rugged Oxygen Generator (ROG) (RO01-00001)?

Rugged Oxygen Generator (ROG) (RO01-00001) is a medical device that received FDA 510(k) clearance on 2024-12-06. The listed applicant is Molecular Products , Ltd.. The 510(k) number is K240561.

When did Rugged Oxygen Generator (ROG) (RO01-00001) receive FDA 510(k) clearance?

Rugged Oxygen Generator (ROG) (RO01-00001) received FDA 510(k) clearance on 2024-12-06, under 510(k) number K240561.

Who is the listed applicant for Rugged Oxygen Generator (ROG) (RO01-00001)?

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

What is the FDA product code for Rugged Oxygen Generator (ROG) (RO01-00001)?

The FDA product code for Rugged Oxygen Generator (ROG) (RO01-00001) is CAW.

相關臨床試驗

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相關器械(代碼:CAW)

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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