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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Monitoring (W/Wo Alarm)
510(k) Number K862687
Device Name OHMEDA 5410 VOLUME MONITOR
Applicant
Ohmeda Medical
355 Inverness Dr.South
Englewood,  CO  80112
Applicant Contact WILLIAM W BELEW
Correspondent
Ohmeda Medical
355 Inverness Dr.South
Englewood,  CO  80112
Correspondent Contact WILLIAM W BELEW
Regulation Number868.1850
Classification Product Code
BZK  
Date Received07/15/1986
Decision Date 09/12/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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