REVEAL LINQ INSERTABLE CARDIAC MONITOR

Detector And Alarm, Arrhythmia

MEDTRONIC INC.

The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Reveal Linq Insertable Cardiac Monitor.

Pre-market Notification Details

Device IDK132649
510k NumberK132649
Device Name:REVEAL LINQ INSERTABLE CARDIAC MONITOR
ClassificationDetector And Alarm, Arrhythmia
Applicant MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View,  MN  55112
ContactEric Kalmes
CorrespondentEric Kalmes
MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View,  MN  55112
Product CodeDSI  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-26
Decision Date2014-02-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169547940 K132649 000
00643169508262 K132649 000
00643169323575 K132649 000

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