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FDA 510(k)

OnQ Neuro

K-Number: K210831 · 2021-11-19

Decision Date2021-11-19
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OnQ Neuro is the device name listed in this FDA 510(k) record. The listed applicant is Cortechs Labs, Inc.. It received FDA 510(k) clearance on 2021-11-19 under 510(k) 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. The listed applicant is Cortechs Labs, Inc.. The 510(k) number is K210831.

When did OnQ Neuro receive FDA 510(k) clearance?

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

Who is the listed applicant for OnQ Neuro?

The FDA 510(k) record lists Cortechs Labs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OnQ Neuro?

The FDA product code for OnQ Neuro is QIH.

Other records listing Cortechs Labs, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: QIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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