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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Breathing Frequency
510(k) Number K984431
Device Name ULTIMA AIRFLOW PRESSURE 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 Number868.2375
Classification Product Code
BZQ  
Date Received12/11/1998
Decision Date 12/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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