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FDA 510(k)

OnQ Neuro

K-Number: K210831 · 2021-11-19

ApplicantCortechs Labs, Inc.
Decision Date2021-11-19
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OnQ Neuro is a medical device manufactured by Cortechs Labs, Inc.. It received FDA 510(k) clearance on 2021-11-19 under approval number K210831. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OnQ Neuro?

OnQ Neuro is a medical device that received FDA 510(k) clearance on 2021-11-19. It is manufactured by Cortechs Labs, Inc.. The 510(k) number is K210831.

When was OnQ Neuro approved by the FDA?

OnQ Neuro received FDA 510(k) clearance on 2021-11-19, under approval number K210831.

What company makes OnQ Neuro?

OnQ Neuro is manufactured by Cortechs Labs, Inc..

What is the FDA product code for OnQ Neuro?

The FDA product code for OnQ Neuro is QIH.

Other Devices by Cortechs Labs, Inc.

K170981NeuroQuant K241098NeuroQuant

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Official Source

View on FDA Database →

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

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