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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 K962648
Device Name OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOR
Applicant
OHMEDA MEDICAL
1315 W. LOUISVILLE DR.
LOUISVILLE,  CO  80027
Applicant Contact BILL CURNAN
Correspondent
OHMEDA MEDICAL
1315 W. LOUISVILLE DR.
LOUISVILLE,  CO  80027
Correspondent Contact BILL CURNAN
Regulation Number868.1500
Classification Product Code
CBQ  
Date Received07/08/1996
Decision Date 01/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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