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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 K923276
Device Name CAPNOMAC ULTIMA ANESTHESIA MONITOR
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 Number868.1500
Classification Product Code
CBQ  
Date Received07/06/1992
Decision Date 07/21/1993
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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