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FDA 510(k)

COPRO 3

K-Number: K241672 · 2024-09-06

ApplicantAmt Engineering Co., Ltd.
Decision Date2024-09-06
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COPRO 3 is the device name listed in this FDA 510(k) record. The listed applicant is Amt Engineering Co., Ltd.. It received FDA 510(k) clearance on 2024-09-06 under 510(k) number K241672. 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 COPRO 3?

COPRO 3 is a medical device that received FDA 510(k) clearance on 2024-09-06. The listed applicant is Amt Engineering Co., Ltd.. The 510(k) number is K241672.

When did COPRO 3 receive FDA 510(k) clearance?

COPRO 3 received FDA 510(k) clearance on 2024-09-06, under 510(k) number K241672.

Who is the listed applicant for COPRO 3?

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

What is the FDA product code for COPRO 3?

The FDA product code for COPRO 3 is GEX. This falls under the Gastroenterology category.

Other records listing Amt Engineering 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.

K230340Lucas Plus

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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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