FDA 510(k)

DEKA PHYSIQ 360

K 號：K231971 · 2023-09-26

決定日期2023-09-26

產品代碼PKT

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

DEKA PHYSIQ 360 is the device name listed in this FDA 510(k) record. The listed applicant is El.En S.P.A.. It received FDA 510(k) clearance on 2023-09-26 under 510(k) number K231971. The device is classified under product code PKT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DEKA PHYSIQ 360?

DEKA PHYSIQ 360 is a medical device that received FDA 510(k) clearance on 2023-09-26. The listed applicant is El.En S.P.A.. The 510(k) number is K231971.

When did DEKA PHYSIQ 360 receive FDA 510(k) clearance?

DEKA PHYSIQ 360 received FDA 510(k) clearance on 2023-09-26, under 510(k) number K231971.

Who is the listed applicant for DEKA PHYSIQ 360?

The FDA 510(k) record lists El.En S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEKA PHYSIQ 360?

The FDA product code for DEKA PHYSIQ 360 is PKT.

其他以 El.En S.P.A. 為申請人之記錄

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官方來源

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