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FDA 510(k)

SANDRO Dual

K-Number: K200110 · 2020-03-16

ApplicantWontech Co., Ltd.
Decision Date2020-03-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SANDRO Dual 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 2020-03-16 under 510(k) number K200110. 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 SANDRO Dual?

SANDRO Dual is a medical device that received FDA 510(k) clearance on 2020-03-16. The listed applicant is Wontech Co., Ltd.. The 510(k) number is K200110.

When did SANDRO Dual receive FDA 510(k) clearance?

SANDRO Dual received FDA 510(k) clearance on 2020-03-16, under 510(k) number K200110.

Who is the listed applicant for SANDRO Dual?

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 SANDRO Dual?

The FDA product code for SANDRO Dual 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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