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FDA 510(k)

Tri Auto ZX2

K-Number: K170275 · 2017-09-11

ApplicantJ. Morita USA, Inc.
Decision Date2017-09-11
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Tri Auto ZX2 is a medical device manufactured by J. Morita USA, Inc.. It received FDA 510(k) clearance on 2017-09-11 under approval number K170275. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tri Auto ZX2?

Tri Auto ZX2 is a medical device that received FDA 510(k) clearance on 2017-09-11. It is manufactured by J. Morita USA, Inc.. The 510(k) number is K170275.

When was Tri Auto ZX2 approved by the FDA?

Tri Auto ZX2 received FDA 510(k) clearance on 2017-09-11, under approval number K170275.

What company makes Tri Auto ZX2?

Tri Auto ZX2 is manufactured by J. Morita USA, Inc..

What is the FDA product code for Tri Auto ZX2?

The FDA product code for Tri Auto ZX2 is EKX.

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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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