NeuroQ 3.8— 510(k) K180077

Substantially Equivalent

Syntermed

FDA 510(k) clearance K180077 for NeuroQ 3.8, Substantially Equivalent on 2018-08-16. Applicant: Syntermed. Device class: 2.

Clearance details

Applicant: Syntermed
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2018-01-10
Decision date: 2018-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.