EP-WORKMATE SYSTEM, VERSION 4.2

Computer, Diagnostic, Programmable

ST. JUDE MEDICAL

The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Ep-workmate System, Version 4.2.

Pre-market Notification Details

Device IDK092810
510k NumberK092810
Device Name:EP-WORKMATE SYSTEM, VERSION 4.2
ClassificationComputer, Diagnostic, Programmable
Applicant ST. JUDE MEDICAL 575 ROUTE 73 N BUILDING D West Berlin,  NJ  08901
ContactTimothy J Kappers
CorrespondentTimothy J Kappers
ST. JUDE MEDICAL 575 ROUTE 73 N BUILDING D West Berlin,  NJ  08901
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-11
Decision Date2009-10-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05415067003560 K092810 000
05414734219105 K092810 000
05415067000866 K092810 000
05415067000965 K092810 000
05415067000972 K092810 000
05415067003119 K092810 000
05415067003126 K092810 000
05415067003461 K092810 000
05415067003553 K092810 000
05414734207546 K092810 000

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