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FDA 510(k)

inVisionOS

K-Number: K210344 · 2021-11-10

ApplicantPrecisionos Technology, Inc.
Decision Date2021-11-10
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

inVisionOS is a medical device manufactured by Precisionos Technology, Inc.. It received FDA 510(k) clearance on 2021-11-10 under approval number K210344. 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 inVisionOS?

inVisionOS is a medical device that received FDA 510(k) clearance on 2021-11-10. It is manufactured by Precisionos Technology, Inc.. The 510(k) number is K210344.

When was inVisionOS approved by the FDA?

inVisionOS received FDA 510(k) clearance on 2021-11-10, under approval number K210344.

What company makes inVisionOS?

inVisionOS is manufactured by Precisionos Technology, Inc..

What is the FDA product code for inVisionOS?

The FDA product code for inVisionOS is LLZ.

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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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