REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528

Detector And Alarm, Arrhythmia

MEDTRONIC INC.

The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Reveal Xt Insertable Cardiac Monitor, Model 9529 And Reveal Dx Insertable Cardiac Monitor, Model 9528.

Pre-market Notification Details

Device IDK103764
510k NumberK103764
Device Name:REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528
ClassificationDetector And Alarm, Arrhythmia
Applicant MEDTRONIC INC. 8200 CORAL SEA ST NE Mounds View,  MN  55112
ContactYukiko Corson
CorrespondentYukiko Corson
MEDTRONIC INC. 8200 CORAL SEA ST NE Mounds View,  MN  55112
Product CodeDSI  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-23
Decision Date2011-05-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169494893 K103764 000
00643169472211 K103764 000
00643169472143 K103764 000
00643169093881 K103764 000

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