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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vectorcardiograph
510(k) Number K023414
Device Name MIDA ALGORITHM REV. B
Applicant
Ortivus AB
Enhagsslingan 5
Taby,  SE SE-18325
Applicant Contact KENNETH EKLUND
Correspondent
Ortivus AB
Enhagsslingan 5
Taby,  SE SE-18325
Correspondent Contact KENNETH EKLUND
Regulation Number870.2400
Classification Product Code
DYC  
Date Received10/11/2002
Decision Date 12/05/2003
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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