FDA 510(k)

I 查看及影像感測器

K 號：K162619 · 2016-11-04

決定日期2016-11-04

產品代碼MUH

諮詢委員會DE

決定相當於

器材摘要

I View and Imagen Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Trident S.R.L. It received FDA 510(k) clearance on 2016-11-04 under 510(k) number K162619. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the I View and Imagen Sensor?

I View and Imagen Sensor is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Trident S.R.L. The 510(k) number is K162619.

When did I View and Imagen Sensor receive FDA 510(k) clearance?

I View and Imagen Sensor received FDA 510(k) clearance on 2016-11-04, under 510(k) number K162619.

Who is the listed applicant for I View and Imagen Sensor?

The FDA 510(k) record lists Trident S.R.L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I View and Imagen Sensor?

The FDA product code for I View and Imagen Sensor is MUH.

其他以 Trident S.R.L 為申請人之記錄

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相關器械（代碼：MUH）

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