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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K170154
Device Name Creavo Vitalscan Magnetocardiograph
Applicant
Creavo Medical Technologies, Ltd.
2020 House, Siskin Dr., Middlemarch Business Park
Coventry,  GB cv3 4fj
Applicant Contact David Dimambro
Correspondent
Halloran Consulting Group, LLC
266 Summer St., 8th Floor
Boston,  MA  02210
Correspondent Contact Sharon L. Timberlake
Regulation Number870.2340
Classification Product Code
DPS  
Date Received01/18/2017
Decision Date 10/12/2017
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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