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FDA 510(k)

FUKUDA DENSHI VASERA MODEL VS-1500

K-Number: K112521 · 2011-12-21

ApplicantFukuda Denshi USA, Inc.
Decision Date2011-12-21
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FUKUDA DENSHI VASERA MODEL VS-1500 is the device name listed in this FDA 510(k) record. The listed applicant is Fukuda Denshi USA, Inc.. It received FDA 510(k) clearance on 2011-12-21 under 510(k) number K112521. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUKUDA DENSHI VASERA MODEL VS-1500?

FUKUDA DENSHI VASERA MODEL VS-1500 is a medical device that received FDA 510(k) clearance on 2011-12-21. The listed applicant is Fukuda Denshi USA, Inc.. The 510(k) number is K112521.

When did FUKUDA DENSHI VASERA MODEL VS-1500 receive FDA 510(k) clearance?

FUKUDA DENSHI VASERA MODEL VS-1500 received FDA 510(k) clearance on 2011-12-21, under 510(k) number K112521.

Who is the listed applicant for FUKUDA DENSHI VASERA MODEL VS-1500?

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

What is the FDA product code for FUKUDA DENSHI VASERA MODEL VS-1500?

The FDA product code for FUKUDA DENSHI VASERA MODEL VS-1500 is DXN.

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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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