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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 K982216
Device Name ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522
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 Received06/23/1998
Decision Date 09/11/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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