FDA 510(k)

PHOENIX/AeroDR TX m01 及 PHOENIX/mKDR Xpress。

K 號：K221803 · 2022-07-18

決定日期2022-07-18

產品代碼IZL

諮詢委員會RA

決定相當於

器材摘要

PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. is the device name listed in this FDA 510(k) record. The listed applicant is Sedecal., Sa.. It received FDA 510(k) clearance on 2022-07-18 under 510(k) number K221803. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.?

PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. is a medical device that received FDA 510(k) clearance on 2022-07-18. The listed applicant is Sedecal., Sa.. The 510(k) number is K221803.

When did PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. receive FDA 510(k) clearance?

PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. received FDA 510(k) clearance on 2022-07-18, under 510(k) number K221803.

Who is the listed applicant for PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.?

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

What is the FDA product code for PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.?

The FDA product code for PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. is IZL.

其他以 Sedecal., Sa. 為申請人之記錄

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相關器械（代碼：IZL）

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