FDA 510(k)

Zmaxx T Series

K-Number: K161219 · 2017-01-26

Decision Date2017-01-26

Product CodeEIH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Zmaxx T Series is the device name listed in this FDA 510(k) record. The listed applicant is Maxx Digm, Inc.. It received FDA 510(k) clearance on 2017-01-26 under 510(k) 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. The listed applicant is Maxx Digm, Inc.. The 510(k) number is K161219.

When did Zmaxx T Series receive FDA 510(k) clearance?

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

Who is the listed applicant for Zmaxx T Series?

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

What is the FDA product code for Zmaxx T Series?

The FDA product code for Zmaxx T Series is EIH.

Related Devices (Code: EIH)

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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.