SmoothCool HR System
K-Number: K223685 · 2023-01-04
ApplicantJeisys Medical, Inc.
Decision Date2023-01-04
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
SmoothCool HR System is a medical device manufactured by Jeisys Medical, Inc.. It received FDA 510(k) clearance on 2023-01-04 under approval 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.
Frequently Asked Questions
What is the SmoothCool HR System?
SmoothCool HR System is a medical device that received FDA 510(k) clearance on 2023-01-04. It is manufactured by Jeisys Medical, Inc.. The 510(k) number is K223685.
When was SmoothCool HR System approved by the FDA?
SmoothCool HR System received FDA 510(k) clearance on 2023-01-04, under approval number K223685.
What company makes SmoothCool HR System?
SmoothCool HR System is manufactured by Jeisys Medical, Inc..
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.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.