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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 K864603
Device Name DELTATRAC(TM) METABOLIC MONITOR
Applicant
DATEX DIVISION INSTRUMENTARIUM CORP.
127 UPHAM ST.
MELROSE,  MA  02176
Applicant Contact HANNU AHJOPALO
Correspondent
DATEX DIVISION INSTRUMENTARIUM CORP.
127 UPHAM ST.
MELROSE,  MA  02176
Correspondent Contact HANNU AHJOPALO
Regulation Number868.1730
Classification Product Code
BZL  
Date Received11/24/1986
Decision Date 03/17/1987
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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