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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 K895586
Device Name VVR/Q CALORIMETER
Applicant
Vita-Stat
540 S. Andreasen
Suite J
Escondido,  CA  92025
Applicant Contact DENNIS IRLBECK
Correspondent
Vita-Stat
540 S. Andreasen
Suite J
Escondido,  CA  92025
Correspondent Contact DENNIS IRLBECK
Regulation Number868.1730
Classification Product Code
BZL  
Date Received09/15/1989
Decision Date 09/22/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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