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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, Carbon-Dioxide, Gaseous-Phase
510(k) Number K896652
Device Name CAPNOMAC ULTIMA(TM) ANESTHESIA MONITOR
Applicant
DATEX DIVISION INSTRUMENTARIUM CORP.
P.O. BOX 446
SF-00101
HELSINKI, FINLAND,  FI
Applicant Contact HANNU AHJOPALO
Correspondent
DATEX DIVISION INSTRUMENTARIUM CORP.
P.O. BOX 446
SF-00101
HELSINKI, FINLAND,  FI
Correspondent Contact HANNU AHJOPALO
Regulation Number868.1400
Classification Product Code
CCK  
Date Received11/24/1989
Decision Date 09/05/1990
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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