EKG SPEAKS

Analyzer, Pacemaker Generator Function, Indirect

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Ekg Speaks.

Pre-market Notification Details

Device IDK032926
510k NumberK032926
Device Name:EKG SPEAKS
ClassificationAnalyzer, Pacemaker Generator Function, Indirect
Applicant MEDTRONIC VASCULAR 7000 CENTRAL AVE. NE Minneapolis,  MN  55432 -3576
ContactKristyn Benson
CorrespondentKristyn Benson
MEDTRONIC VASCULAR 7000 CENTRAL AVE. NE Minneapolis,  MN  55432 -3576
Product CodeKRE  
CFR Regulation Number870.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-22
Decision Date2003-10-15
Summary:summary

Trademark Results [EKG SPEAKS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EKG SPEAKS
EKG SPEAKS
75700956 2393076 Dead/Cancelled
Paceart Associates, L.P.
1999-05-07

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