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FDA 510(k)

Secret Duo

K-Number: K202043 · 2021-04-23

ApplicantIlooda Co,., Ltd.
Decision Date2021-04-23
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Secret Duo is the device name listed in this FDA 510(k) record. The listed applicant is Ilooda Co,., Ltd.. It received FDA 510(k) clearance on 2021-04-23 under 510(k) number K202043. 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 Secret Duo?

Secret Duo is a medical device that received FDA 510(k) clearance on 2021-04-23. The listed applicant is Ilooda Co,., Ltd.. The 510(k) number is K202043.

When did Secret Duo receive FDA 510(k) clearance?

Secret Duo received FDA 510(k) clearance on 2021-04-23, under 510(k) number K202043.

Who is the listed applicant for Secret Duo?

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

What is the FDA product code for Secret Duo?

The FDA product code for Secret Duo is GEX. This falls under the Gastroenterology category.

Other records listing Ilooda 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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