FDA 510(k)

UF-760AG

K-Number: K110920 · 2011-04-08

Decision Date2011-04-08

Product CodeITX

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

UF-760AG is the device name listed in this FDA 510(k) record. The listed applicant is Fukuda Denshi Co., Ltd.. It received FDA 510(k) clearance on 2011-04-08 under 510(k) number K110920. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UF-760AG?

UF-760AG is a medical device that received FDA 510(k) clearance on 2011-04-08. The listed applicant is Fukuda Denshi Co., Ltd.. The 510(k) number is K110920.

When did UF-760AG receive FDA 510(k) clearance?

UF-760AG received FDA 510(k) clearance on 2011-04-08, under 510(k) number K110920.

Who is the listed applicant for UF-760AG?

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

What is the FDA product code for UF-760AG?

The FDA product code for UF-760AG is ITX.

Other records listing Fukuda Denshi 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.