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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Oxygen-Uptake
510(k) Number K931422
Device Name DELTATRAC(TM) II METABOLIC 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 Number868.1730
Classification Product Code
BZL  
Date Received03/22/1993
Decision Date 11/24/1993
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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