FDA 510(k)

德卡蒂亞1

K 號：K183371 · 2019-12-03

決定日期2019-12-03

產品代碼PBX

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 Tiac 1 is the device name listed in this FDA 510(k) record. The listed applicant is El..En. Electroic Engineering Spa. It received FDA 510(k) clearance on 2019-12-03 under 510(k) number K183371. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Deka Tiac 1?

Deka Tiac 1 is a medical device that received FDA 510(k) clearance on 2019-12-03. The listed applicant is El..En. Electroic Engineering Spa. The 510(k) number is K183371.

When did Deka Tiac 1 receive FDA 510(k) clearance?

Deka Tiac 1 received FDA 510(k) clearance on 2019-12-03, under 510(k) number K183371.

Who is the listed applicant for Deka Tiac 1?

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

What is the FDA product code for Deka Tiac 1?

The FDA product code for Deka Tiac 1 is PBX.

相關器械（代碼：PBX）

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