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FDA 510(k)

XR90 (XR90-SYS)

K-Number: K223125 · 2023-07-13

ApplicantMediview Xr, Inc.
Decision Date2023-07-13
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XR90 (XR90-SYS) is a medical device manufactured by Mediview Xr, Inc.. It received FDA 510(k) clearance on 2023-07-13 under approval number K223125. 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 XR90 (XR90-SYS)?

XR90 (XR90-SYS) is a medical device that received FDA 510(k) clearance on 2023-07-13. It is manufactured by Mediview Xr, Inc.. The 510(k) number is K223125.

When was XR90 (XR90-SYS) approved by the FDA?

XR90 (XR90-SYS) received FDA 510(k) clearance on 2023-07-13, under approval number K223125.

What company makes XR90 (XR90-SYS)?

XR90 (XR90-SYS) is manufactured by Mediview Xr, Inc..

What is the FDA product code for XR90 (XR90-SYS)?

The FDA product code for XR90 (XR90-SYS) is LLZ.

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Official Source

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