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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
510(k) Number K931439
Device Name OHMEDA MODEL 5330 ANESTHETIC MONITOR
Applicant
OHMEDA MEDICAL
1315 W. LOUISVILLE DR.
LOUISVILLE,  CO  80027
Applicant Contact KEVIN MORNINGSTAR
Correspondent
OHMEDA MEDICAL
1315 W. LOUISVILLE DR.
LOUISVILLE,  CO  80027
Correspondent Contact KEVIN MORNINGSTAR
Regulation Number868.1500
Classification Product Code
CBQ  
Date Received03/22/1993
Decision Date 10/19/1993
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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