OnQ Neuro— 510(k) K210831

Substantially Equivalent

Cortechs Labs, Inc.

FDA 510(k) clearance K210831 for OnQ Neuro, Substantially Equivalent on 2021-11-19. Applicant: Cortechs Labs, Inc.. Device class: 2.

Clearance details

Applicant: Cortechs Labs, Inc.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2021-03-19
Decision date: 2021-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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