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FDA 510(k)

Root ZX3

K-Number: K213477 · 2022-08-03

ApplicantJ. Morita USA, Inc.
Decision Date2022-08-03
Product CodeEKZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Root ZX3 is a medical device manufactured by J. Morita USA, Inc.. It received FDA 510(k) clearance on 2022-08-03 under approval number K213477. The device is classified under product code EKZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Root ZX3?

Root ZX3 is a medical device that received FDA 510(k) clearance on 2022-08-03. It is manufactured by J. Morita USA, Inc.. The 510(k) number is K213477.

When was Root ZX3 approved by the FDA?

Root ZX3 received FDA 510(k) clearance on 2022-08-03, under approval number K213477.

What company makes Root ZX3?

Root ZX3 is manufactured by J. Morita USA, Inc..

What is the FDA product code for Root ZX3?

The FDA product code for Root ZX3 is EKZ.

Other Devices by J. Morita USA, Inc.

K171012Veraview X800 K170275Tri Auto ZX2 K173920LS OIL K190509Lubrina 2 K2013783D Accuitomo 150N

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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