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FDA 510(k)

IntraOp VSP Software Device

K-Number: K213128 · 2022-10-21

ApplicantXironetic, LLC
Decision Date2022-10-21
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IntraOp VSP Software Device is a medical device manufactured by Xironetic, LLC. It received FDA 510(k) clearance on 2022-10-21 under approval number K213128. 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 IntraOp VSP Software Device?

IntraOp VSP Software Device is a medical device that received FDA 510(k) clearance on 2022-10-21. It is manufactured by Xironetic, LLC. The 510(k) number is K213128.

When was IntraOp VSP Software Device approved by the FDA?

IntraOp VSP Software Device received FDA 510(k) clearance on 2022-10-21, under approval number K213128.

What company makes IntraOp VSP Software Device?

IntraOp VSP Software Device is manufactured by Xironetic, LLC.

What is the FDA product code for IntraOp VSP Software Device?

The FDA product code for IntraOp VSP Software Device is LLZ.

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Related PubMed Literature

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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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