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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas-Machine, Anesthesia
510(k) Number K945234
Device Name AS/3 MEMORY MODULE, M0MEM
Applicant
DATEX DIVISION INSTRUMENTARIUM CORP.
P.O. BOX 446
SF-00101
HELSINKI, FINLAND,  FI
Applicant Contact ANTTI RITVOS
Correspondent
DATEX DIVISION INSTRUMENTARIUM CORP.
P.O. BOX 446
SF-00101
HELSINKI, FINLAND,  FI
Correspondent Contact ANTTI RITVOS
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received10/27/1994
Decision Date 01/27/1995
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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