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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 K895935
Device Name ICOR CMU Q PLUS
Applicant
Icor AB
Ulvsundavagen 178 B
Bromma,  SE 161 30
Applicant Contact GEDEON, PHD
Correspondent
Icor AB
Ulvsundavagen 178 B
Bromma,  SE 161 30
Correspondent Contact GEDEON, PHD
Regulation Number868.1730
Classification Product Code
BZL  
Date Received10/11/1989
Decision Date 01/04/1990
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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