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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K042628
Device Name MODIFICATION TO: RADIANALYZER, MODEL 12711
Applicant
RADI MEDICAL SYSTEMS AB
PALMBLADSGATAN 10
UPPSALA,  SE S-754 50
Applicant Contact HELENE EKSTRAND
Correspondent
RADI MEDICAL SYSTEMS AB
PALMBLADSGATAN 10
UPPSALA,  SE S-754 50
Correspondent Contact HELENE EKSTRAND
Regulation Number870.1425
Classification Product Code
DQK  
Date Received09/27/2004
Decision Date 01/19/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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