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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
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