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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, airway pressure (includes gauge and/or alarm)
510(k) Number K864536
Device Name OHMEDA 5500 AIRWAY PRESSURE MONITOR
Applicant
OHMEDA MEDICAL
355 INVERNESS DR.SOUTH
ENGLEWOOD,  CO  80112 -5810
Applicant Contact WILLIAM W BELEW
Correspondent
OHMEDA MEDICAL
355 INVERNESS DR.SOUTH
ENGLEWOOD,  CO  80112 -5810
Correspondent Contact WILLIAM W BELEW
Regulation Number868.2600
Classification Product Code
CAP  
Date Received11/17/1986
Decision Date 01/12/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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