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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 K210543
Device Name IM007
Applicant
Implicity, Inc.
185 Alewife Brook Parkway Suite 210
Cambridge,  MA  02138
Applicant Contact David Perlmutter
Correspondent
MJ Medtech Consulting Services LLC
24125 Butteville Rd. NE
Aurora,  OR  97002
Correspondent Contact Mark Johnson
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Code
DPS  
Date Received02/24/2021
Decision Date 11/03/2021
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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