FDA 510(k)

AeroDR TX c02

K 號：K253446 · 2026-04-10

決定日期2026-04-10

產品代碼KPR

諮詢委員會RA

決定相當於

器材摘要

AeroDR TX c02 is the device name listed in this FDA 510(k) record. The listed applicant is Dk Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2026-04-10 under 510(k) number K253446. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AeroDR TX c02?

AeroDR TX c02 is a medical device that received FDA 510(k) clearance on 2026-04-10. The listed applicant is Dk Medical Systems Co., Ltd.. The 510(k) number is K253446.

When did AeroDR TX c02 receive FDA 510(k) clearance?

AeroDR TX c02 received FDA 510(k) clearance on 2026-04-10, under 510(k) number K253446.

Who is the listed applicant for AeroDR TX c02?

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

What is the FDA product code for AeroDR TX c02?

The FDA product code for AeroDR TX c02 is KPR.

其他以 Dk Medical Systems Co., 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：KPR）

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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