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FDA 510(k)

雷射Dock, 騷石Dock, 二氧化碳Dock, OmniDock, KTPDock

K 號：K170215 · 2017-04-19

申請人Patient Pocket, LLC
決定日期2017-04-19
產品代碼GEX
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

LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock is the device name listed in this FDA 510(k) record. The listed applicant is Patient Pocket, LLC. It received FDA 510(k) clearance on 2017-04-19 under 510(k) number K170215. 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.

常見問題

What is the LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock?

LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock is a medical device that received FDA 510(k) clearance on 2017-04-19. The listed applicant is Patient Pocket, LLC. The 510(k) number is K170215.

When did LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock receive FDA 510(k) clearance?

LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock received FDA 510(k) clearance on 2017-04-19, under 510(k) number K170215.

Who is the listed applicant for LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock?

The FDA 510(k) record lists Patient Pocket, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock?

The FDA product code for LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock is GEX. This falls under the Gastroenterology category.

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