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FDA 510(k)

PaX-i3D Green Premium (Model: PCT-90LH)

K-Number: K160882 · 2016-10-28

ApplicantVATECH Co., Ltd.
Decision Date2016-10-28
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PaX-i3D Green Premium (Model: PCT-90LH) is a medical device manufactured by VATECH Co., Ltd.. It received FDA 510(k) clearance on 2016-10-28 under approval number K160882. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PaX-i3D Green Premium (Model: PCT-90LH)?

PaX-i3D Green Premium (Model: PCT-90LH) is a medical device that received FDA 510(k) clearance on 2016-10-28. It is manufactured by VATECH Co., Ltd.. The 510(k) number is K160882.

When was PaX-i3D Green Premium (Model: PCT-90LH) approved by the FDA?

PaX-i3D Green Premium (Model: PCT-90LH) received FDA 510(k) clearance on 2016-10-28, under approval number K160882.

What company makes PaX-i3D Green Premium (Model: PCT-90LH)?

PaX-i3D Green Premium (Model: PCT-90LH) is manufactured by VATECH Co., Ltd..

What is the FDA product code for PaX-i3D Green Premium (Model: PCT-90LH)?

The FDA product code for PaX-i3D Green Premium (Model: PCT-90LH) is OAS.

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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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