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FDA 510(k)

SmoothCool HR System

K-Number: K213484 · 2022-04-20

ApplicantJeisys Medical, Inc.
Decision Date2022-04-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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 2022-04-20 under 510(k) number K213484. 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 2022-04-20. The listed applicant is Jeisys Medical, Inc.. The 510(k) number is K213484.

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

SmoothCool HR System received FDA 510(k) clearance on 2022-04-20, under 510(k) number K213484.

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.

Other records listing Jeisys Medical, Inc. as applicant

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Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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