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FDA 510(k)

SurgicalAR

K-Number: K190764 · 2019-05-13

ApplicantMedivis, Inc.
Decision Date2019-05-13
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SurgicalAR is a medical device manufactured by Medivis, Inc.. It received FDA 510(k) clearance on 2019-05-13 under approval number K190764. 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 SurgicalAR?

SurgicalAR is a medical device that received FDA 510(k) clearance on 2019-05-13. It is manufactured by Medivis, Inc.. The 510(k) number is K190764.

When was SurgicalAR approved by the FDA?

SurgicalAR received FDA 510(k) clearance on 2019-05-13, under approval number K190764.

What company makes SurgicalAR?

SurgicalAR is manufactured by Medivis, Inc..

What is the FDA product code for SurgicalAR?

The FDA product code for SurgicalAR is LLZ.

Other Devices by Medivis, Inc.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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