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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 K933284
Device Name AS/3 TM NETWORK
Applicant
DATEX DIVISION INSTRUMENTARIUM CORP.
27 TEOLLISUUSKATU
HELSINKI,  FI
Applicant Contact HANNU AHJOPALO
Correspondent
DATEX DIVISION INSTRUMENTARIUM CORP.
27 TEOLLISUUSKATU
HELSINKI,  FI
Correspondent Contact HANNU AHJOPALO
Regulation Number868.1400
Classification Product Code
CCK  
Date Received07/06/1993
Decision Date 07/11/1994
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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