Holinwon 30
K-Number: K183563 · 2019-09-05
ApplicantWontech Co., Ltd.
Decision Date2019-09-05
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Holinwon 30 is a medical device manufactured by Wontech Co., Ltd.. It received FDA 510(k) clearance on 2019-09-05 under approval number K183563. 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 Holinwon 30?
Holinwon 30 is a medical device that received FDA 510(k) clearance on 2019-09-05. It is manufactured by Wontech Co., Ltd.. The 510(k) number is K183563.
When was Holinwon 30 approved by the FDA?
Holinwon 30 received FDA 510(k) clearance on 2019-09-05, under approval number K183563.
What company makes Holinwon 30?
Holinwon 30 is manufactured by Wontech Co., Ltd..
What is the FDA product code for Holinwon 30?
The FDA product code for Holinwon 30 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.