FDA 510(k)

Dyna-Vision Telemonitoring System

K-Number: K152973 · 2016-04-29

ApplicantTechmedic Development International B.V.

Decision Date2016-04-29

Product CodeMHX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Dyna-Vision Telemonitoring System is a medical device manufactured by Techmedic Development International B.V.. It received FDA 510(k) clearance on 2016-04-29 under approval number K152973. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dyna-Vision Telemonitoring System?

Dyna-Vision Telemonitoring System is a medical device that received FDA 510(k) clearance on 2016-04-29. It is manufactured by Techmedic Development International B.V.. The 510(k) number is K152973.

When was Dyna-Vision Telemonitoring System approved by the FDA?

Dyna-Vision Telemonitoring System received FDA 510(k) clearance on 2016-04-29, under approval number K152973.

What company makes Dyna-Vision Telemonitoring System?

Dyna-Vision Telemonitoring System is manufactured by Techmedic Development International B.V..

What is the FDA product code for Dyna-Vision Telemonitoring System?

The FDA product code for Dyna-Vision Telemonitoring System is MHX.

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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.