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FDA 510(k)

Azure

K-Number: K231514 · 2024-02-14

ApplicantDaeshin Enterprise Co., Ltd.
Decision Date2024-02-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Azure is the device name listed in this FDA 510(k) record. The listed applicant is Daeshin Enterprise Co., Ltd.. It received FDA 510(k) clearance on 2024-02-14 under 510(k) number K231514. 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 Azure?

Azure is a medical device that received FDA 510(k) clearance on 2024-02-14. The listed applicant is Daeshin Enterprise Co., Ltd.. The 510(k) number is K231514.

When did Azure receive FDA 510(k) clearance?

Azure received FDA 510(k) clearance on 2024-02-14, under 510(k) number K231514.

Who is the listed applicant for Azure?

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

What is the FDA product code for Azure?

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

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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