Positional Sleep Assessment System (PoSAS) software— 510(k) K172799

Substantially Equivalent

Advanced Brain Monitoring

FDA 510(k) clearance K172799 for Positional Sleep Assessment System (PoSAS) software, Substantially Equivalent on 2018-03-09. Applicant: Advanced Brain Monitoring. Device class: 2.

Clearance details

Applicant
Advanced Brain Monitoring
Product code
Code MNR
Device class
Class 2
Regulation
21 CFR 868.2375
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Carlsbad, CA, US
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