FDA 510(k)

SmoothCool HR 系統

K 號：K223685 · 2023-01-04

決定日期2023-01-04

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

SmoothCool HR System is the device name listed in this FDA 510(k) record. The listed applicant is Jeisys Medical, Inc.. It received FDA 510(k) clearance on 2023-01-04 under 510(k) number K223685. 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 SmoothCool HR System?

SmoothCool HR System is a medical device that received FDA 510(k) clearance on 2023-01-04. The listed applicant is Jeisys Medical, Inc.. The 510(k) number is K223685.

When did SmoothCool HR System receive FDA 510(k) clearance?

SmoothCool HR System received FDA 510(k) clearance on 2023-01-04, under 510(k) number K223685.

Who is the listed applicant for SmoothCool HR System?

The FDA 510(k) record lists Jeisys Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SmoothCool HR System?

The FDA product code for SmoothCool HR System is GEX. This falls under the Gastroenterology category.

其他以 Jeisys Medical, Inc. 為申請人之記錄

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