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FDA 510(k)

Zmaxx T Series

K-Number: K161219 · 2017-01-26

ApplicantMaxx Digm, Inc.
Decision Date2017-01-26
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Zmaxx T Series is a medical device manufactured by Maxx Digm, Inc.. It received FDA 510(k) clearance on 2017-01-26 under approval number K161219. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zmaxx T Series?

Zmaxx T Series is a medical device that received FDA 510(k) clearance on 2017-01-26. It is manufactured by Maxx Digm, Inc.. The 510(k) number is K161219.

When was Zmaxx T Series approved by the FDA?

Zmaxx T Series received FDA 510(k) clearance on 2017-01-26, under approval number K161219.

What company makes Zmaxx T Series?

Zmaxx T Series is manufactured by Maxx Digm, Inc..

What is the FDA product code for Zmaxx T Series?

The FDA product code for Zmaxx T Series is EIH.

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Official Source

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