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FDA 510(k)

Xenoview VDP

K-Number: K223071 · 2022-12-23

ApplicantPolarean, Inc.
Decision Date2022-12-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Xenoview VDP is a medical device manufactured by Polarean, Inc.. It received FDA 510(k) clearance on 2022-12-23 under approval number K223071. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Xenoview VDP?

Xenoview VDP is a medical device that received FDA 510(k) clearance on 2022-12-23. It is manufactured by Polarean, Inc.. The 510(k) number is K223071.

When was Xenoview VDP approved by the FDA?

Xenoview VDP received FDA 510(k) clearance on 2022-12-23, under approval number K223071.

What company makes Xenoview VDP?

Xenoview VDP is manufactured by Polarean, Inc..

What is the FDA product code for Xenoview VDP?

The FDA product code for Xenoview VDP is LLZ.

Other Devices by Polarean, Inc.

K212239XENOVIEW 3.0T Chest Coil K231647XENOVIEW 3.0T Chest Coil K243316XENOVIEW 3.0T Chest Coil

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Official Source

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