NIGHT SHIFT— 510(k) K140190

Substantially Equivalent

Advanced Brain Monitoring, Inc.

FDA 510(k) clearance K140190 for NIGHT SHIFT, Substantially Equivalent on 2014-05-29. Applicant: Advanced Brain Monitoring, Inc.. Device class: 2.

Clearance details

Applicant: Advanced Brain Monitoring, Inc.
Product code: Code MYB
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2014-01-24
Decision date: 2014-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dousman, WI, 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.