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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 K152160
Device Name Navik 3D
Applicant
APN Health, LLC
4900 Hopyard Road, Suite 100
Pleasanton,  CA  94588
Applicant Contact David Geddam
Correspondent
Decus Biomedical Inc
2342 Shattuck Ave, #333
Berkeley,  CA  94704
Correspondent Contact Grace Bartoo
Regulation Number870.1425
Classification Product Code
DQK  
Date Received08/03/2015
Decision Date 02/23/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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