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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 K170948
Device Name AcQMap High Resolution Imaging and Mapping System
Applicant
Acutus Medical, Inc.
2210 Faraday Ave., Suite 100
Carlsbad,  CA  92008
Applicant Contact Brenda Clay
Correspondent
Acutus Medical, Inc.
2210 Faraday Ave., Suite 100
Carlsbad,  CA  92008
Correspondent Contact Brenda Clay
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Codes
ITX   IYO  
Date Received03/30/2017
Decision Date 10/16/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT01875614
NCT01914549
NCT01921660
NCT02469623
NCT02469649
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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