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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
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