WorkMate Claris System

Computer, Diagnostic, Programmable

Abbott

The following data is part of a premarket notification filed by Abbott with the FDA for Workmate Claris System.

Pre-market Notification Details

Device IDK210392
510k NumberK210392
Device Name:WorkMate Claris System
ClassificationComputer, Diagnostic, Programmable
Applicant Abbott One St. Jude Medical Drive St. Paul,  MN  55117
ContactEd Sandberg
CorrespondentEd Sandberg
Abbott One St. Jude Medical Drive St. Paul,  MN  55117
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-10
Decision Date2021-03-11

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.