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FDA 510(k)

ZenPro 40

K-Number: K230268 · 2023-08-10

ApplicantBLUECORE COMPANY Co., Ltd.
Decision Date2023-08-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ZenPro 40 is the device name listed in this FDA 510(k) record. The listed applicant is BLUECORE COMPANY Co., Ltd.. It received FDA 510(k) clearance on 2023-08-10 under 510(k) number K230268. 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 ZenPro 40?

ZenPro 40 is a medical device that received FDA 510(k) clearance on 2023-08-10. The listed applicant is BLUECORE COMPANY Co., Ltd.. The 510(k) number is K230268.

When did ZenPro 40 receive FDA 510(k) clearance?

ZenPro 40 received FDA 510(k) clearance on 2023-08-10, under 510(k) number K230268.

Who is the listed applicant for ZenPro 40?

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

What is the FDA product code for ZenPro 40?

The FDA product code for ZenPro 40 is GEX. This falls under the Gastroenterology category.

Other records listing BLUECORE COMPANY Co., Ltd. as applicant

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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