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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K840232
Device Name ABM ANESTHESIA & BRAIN MONITOR
Applicant
Datex Division Instrumentarium Corp.
P.O. Box 357
Sf-00101
Helsinki 10 Finland, 
Correspondent
Datex Division Instrumentarium Corp.
P.O. Box 357
Sf-00101
Helsinki 10 Finland, 
Date Received01/10/1984
Decision Date 04/06/1984
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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