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FDA 510(k)

U-RIGHT TD-3128 BLOOD PRESSURE MONITORING SYSTEM

K-Number: K112216 · 2011-12-22

ApplicantTaidoc Technology Corporation
Decision Date2011-12-22
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

U-RIGHT TD-3128 BLOOD PRESSURE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Taidoc Technology Corporation. It received FDA 510(k) clearance on 2011-12-22 under 510(k) number K112216. 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 U-RIGHT TD-3128 BLOOD PRESSURE MONITORING SYSTEM?

U-RIGHT TD-3128 BLOOD PRESSURE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2011-12-22. The listed applicant is Taidoc Technology Corporation. The 510(k) number is K112216.

When did U-RIGHT TD-3128 BLOOD PRESSURE MONITORING SYSTEM receive FDA 510(k) clearance?

U-RIGHT TD-3128 BLOOD PRESSURE MONITORING SYSTEM received FDA 510(k) clearance on 2011-12-22, under 510(k) number K112216.

Who is the listed applicant for U-RIGHT TD-3128 BLOOD PRESSURE MONITORING SYSTEM?

The FDA 510(k) record lists Taidoc Technology Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U-RIGHT TD-3128 BLOOD PRESSURE MONITORING SYSTEM?

The FDA product code for U-RIGHT TD-3128 BLOOD PRESSURE MONITORING SYSTEM is DXN.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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