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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 K041662
Device Name APNEA RISK EVALUATION SYSTEM (ARES)
Applicant
Advanced Brain Monitoring, Inc.
2850 Pio Pico Dr.
Suite A
Carlsbad,  CA  92008
Applicant Contact DANIEL J LEVENDOWSKI
Correspondent
Advanced Brain Monitoring, Inc.
2850 Pio Pico Dr.
Suite A
Carlsbad,  CA  92008
Correspondent Contact DANIEL J LEVENDOWSKI
Regulation Number868.2375
Classification Product Code
MNR  
Date Received06/18/2004
Decision Date 10/14/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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