Computer, Diagnostic, Programmable

Implicity, Inc.

The following data is part of a premarket notification filed by Implicity, Inc. with the FDA for Im007.

Pre-market Notification Details

Device IDK210543
510k NumberK210543
Device Name:IM007
ClassificationComputer, Diagnostic, Programmable
Applicant Implicity, Inc. 185 Alewife Brook Parkway Suite 210 Cambridge,  MA  02138
ContactDavid Perlmutter
CorrespondentMark Johnson
MJ Medtech Consulting Services LLC 24125 Butteville Rd. NE Aurora,  OR  97002
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-24
Decision Date2021-11-03

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