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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilatory effort recorder
510(k) Number K172799
Device Name Positional Sleep Assessment System (PoSAS) software
Applicant
Advanced Brain Monitoring
2237 Faraday Ave, Suite 100
Carlsbad,  CA  92008
Applicant Contact Daniela Soll
Correspondent
Advanced Brain Monitoring
2237 Faraday Ave, Suite 100
Carlsbad,  CA  92008
Correspondent Contact Daniela Soll
Regulation Number868.2375
Classification Product Code
MNR  
Subsequent Product Code
OLZ  
Date Received09/18/2017
Decision Date 03/09/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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