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FDA 510(k)

UM-L20/ UM-L30

K-Number: K982860 · 1999-08-13

ApplicantUnion Medical Engeneering Co., Ltd.
Decision Date1999-08-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UM-L20/ UM-L30 is the device name listed in this FDA 510(k) record. The listed applicant is Union Medical Engeneering Co., Ltd.. It received FDA 510(k) clearance on 1999-08-13 under 510(k) number K982860. 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 UM-L20/ UM-L30?

UM-L20/ UM-L30 is a medical device that received FDA 510(k) clearance on 1999-08-13. The listed applicant is Union Medical Engeneering Co., Ltd.. The 510(k) number is K982860.

When did UM-L20/ UM-L30 receive FDA 510(k) clearance?

UM-L20/ UM-L30 received FDA 510(k) clearance on 1999-08-13, under 510(k) number K982860.

Who is the listed applicant for UM-L20/ UM-L30?

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

What is the FDA product code for UM-L20/ UM-L30?

The FDA product code for UM-L20/ UM-L30 is GEX. This falls under the Gastroenterology category.

Other records listing Union Medical Engeneering 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.

K000222UM-L25

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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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