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FDA 510(k)

UNISCAN -DOA SYSTEM

K-Number: K080347 · 2008-10-09

ApplicantTaiwan Unison Biotech, Inc.
Decision Date2008-10-09
Product CodeDJC
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

UNISCAN -DOA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Taiwan Unison Biotech, Inc.. It received FDA 510(k) clearance on 2008-10-09 under 510(k) number K080347. The device is classified under product code DJC. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNISCAN -DOA SYSTEM?

UNISCAN -DOA SYSTEM is a medical device that received FDA 510(k) clearance on 2008-10-09. The listed applicant is Taiwan Unison Biotech, Inc.. The 510(k) number is K080347.

When did UNISCAN -DOA SYSTEM receive FDA 510(k) clearance?

UNISCAN -DOA SYSTEM received FDA 510(k) clearance on 2008-10-09, under 510(k) number K080347.

Who is the listed applicant for UNISCAN -DOA SYSTEM?

The FDA 510(k) record lists Taiwan Unison Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNISCAN -DOA SYSTEM?

The FDA product code for UNISCAN -DOA SYSTEM is DJC.

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Official Source

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