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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 K071230
Device Name APNEA RISK EVALUATION SYSTEM (ARES), MODEL 600
Applicant
ADVANCED BRAIN MONITORING, INC.
2237 FARADAY AVENUE
SUITE 100
CARLSBAD,  CA  92008
Applicant Contact DANIEL J LEVENDOWSKI
Correspondent
ADVANCED BRAIN MONITORING, INC.
2237 FARADAY AVENUE
SUITE 100
CARLSBAD,  CA  92008
Correspondent Contact DANIEL J LEVENDOWSKI
Regulation Number868.2375
Classification Product Code
MNR  
Date Received05/03/2007
Decision Date 10/03/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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