FDA 510(k)

SkyPulse

K号: K193656 · 2020-03-27

决定日期2020-03-27

产品代码GEX

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决定实质等同

器械摘要

SkyPulse is the device name listed in this FDA 510(k) record. The listed applicant is Fotona D.O.O.. It received FDA 510(k) clearance on 2020-03-27 under 510(k) number K193656. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the SkyPulse?

SkyPulse is a medical device that received FDA 510(k) clearance on 2020-03-27. The listed applicant is Fotona D.O.O.. The 510(k) number is K193656.

When did SkyPulse receive FDA 510(k) clearance?

SkyPulse received FDA 510(k) clearance on 2020-03-27, under 510(k) number K193656.

Who is the listed applicant for SkyPulse?

FDA 510(k)记录显示Fotona D.O.O.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for SkyPulse?

The FDA product code for SkyPulse is GEX. This falls under the Gastroenterology category.

列明Fotona D.O.O.为申报人的其他记录

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