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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 K022188
Device Name RADIANALYZER, MODEL 12710
Applicant
Radi Medical Systems AB
Palmbladsgatan 10
Uppsala,  SE S-754 50
Applicant Contact MATS GRANLUND
Correspondent
Radi Medical Systems AB
Palmbladsgatan 10
Uppsala,  SE S-754 50
Correspondent Contact MATS GRANLUND
Regulation Number870.1425
Classification Product Code
DQK  
Date Received07/05/2002
Decision Date 10/03/2002
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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