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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Sleep Assessment
510(k) Number K981969
Device Name ULTIMA BODY POSITION SENSOR
Applicant
Braebon Medical Corp.
63 Acklam Terrace
Kanata,  CA K2K 2H7
Applicant Contact RICHARD A BONATO
Correspondent
Braebon Medical Corp.
63 Acklam Terrace
Kanata,  CA K2K 2H7
Correspondent Contact RICHARD A BONATO
Regulation Number882.5050
Classification Product Code
LEL  
Date Received06/04/1998
Decision Date 08/20/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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