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FDA 510(k)

ViZion DR + Wireless

K-Number: K160810 · 2016-05-20

ApplicantViztek, LLC
Decision Date2016-05-20
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ViZion DR + Wireless is a medical device manufactured by Viztek, LLC. It received FDA 510(k) clearance on 2016-05-20 under approval number K160810. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ViZion DR + Wireless?

ViZion DR + Wireless is a medical device that received FDA 510(k) clearance on 2016-05-20. It is manufactured by Viztek, LLC. The 510(k) number is K160810.

When was ViZion DR + Wireless approved by the FDA?

ViZion DR + Wireless received FDA 510(k) clearance on 2016-05-20, under approval number K160810.

What company makes ViZion DR + Wireless?

ViZion DR + Wireless is manufactured by Viztek, LLC.

What is the FDA product code for ViZion DR + Wireless?

The FDA product code for ViZion DR + Wireless is MQB.

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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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