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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 K981445
Device Name ULTIMA AIRFLOW SENSOR, 0510
Applicant
Braebon Medical Corp.
63 Acklam Ter.
Kanata,  CA K2K 2H7
Applicant Contact RICHARD A BONATO
Correspondent
Braebon Medical Corp.
63 Acklam Ter.
Kanata,  CA K2K 2H7
Correspondent Contact RICHARD A BONATO
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received04/22/1998
Decision Date 10/05/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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