RhythmView Workstation

Computer, Diagnostic, Programmable

Abbott Electrophysiology

The following data is part of a premarket notification filed by Abbott Electrophysiology with the FDA for Rhythmview Workstation.

Pre-market Notification Details

Device IDK171583
510k NumberK171583
Device Name:RhythmView Workstation
ClassificationComputer, Diagnostic, Programmable
Applicant Abbott Electrophysiology 1530 Obrien Drive, Suite B Menlo Park,  CA  94025
ContactDennis Pozzo
CorrespondentDennis Pozzo
Abbott Electrophysiology 3668 S. Geyer Road, Suite 365 St. Louis,  MO  63127
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-05-31
Decision Date2017-09-01
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.