FDA 510(k)

DEKA SMARTPERIO

K 號：K203396 · 2021-08-23

決定日期2021-08-23

產品代碼NVK

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 SMARTPERIO is the device name listed in this FDA 510(k) record. The listed applicant is El.En Electronic Engineering Spa. It received FDA 510(k) clearance on 2021-08-23 under 510(k) number K203396. The device is classified under product code NVK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DEKA SMARTPERIO?

DEKA SMARTPERIO is a medical device that received FDA 510(k) clearance on 2021-08-23. The listed applicant is El.En Electronic Engineering Spa. The 510(k) number is K203396.

When did DEKA SMARTPERIO receive FDA 510(k) clearance?

DEKA SMARTPERIO received FDA 510(k) clearance on 2021-08-23, under 510(k) number K203396.

Who is the listed applicant for DEKA SMARTPERIO?

The FDA 510(k) record lists El.En Electronic Engineering Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEKA SMARTPERIO?

The FDA product code for DEKA SMARTPERIO is NVK.

其他以 El.En Electronic Engineering Spa 為申請人之記錄

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