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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Wontech Co., Ltd.. It received FDA 510(k) clearance on 2019-09-05 under 510(k) 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. The listed applicant is Wontech Co., Ltd.. The 510(k) number is K183563.

When did Holinwon 30 receive FDA 510(k) clearance?

Holinwon 30 received FDA 510(k) clearance on 2019-09-05, under 510(k) number K183563.

Who is the listed applicant for Holinwon 30?

The FDA 510(k) record lists Wontech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Holinwon 30?

The FDA product code for Holinwon 30 is GEX. This falls under the Gastroenterology category.

Other records listing Wontech Co., Ltd. as applicant

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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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