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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 K933285
Device Name DATEX AS/3 TM ANAESTHESIA MONITOR
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 Number868.5160
Classification Product Code
BSZ  
Date Received07/06/1993
Decision Date 11/14/1994
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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