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 IDK163460
510k NumberK163460
Device Name:Reveal LINQ Insertable Cardiac Monitor
ClassificationDetector And Alarm, Arrhythmia
Applicant MEDTRONIC,INC. 8200 CORAL SEA ST NE Mounds View,  MN  55112
ContactLaura Danielson
CorrespondentLaura Danielson
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 Received2016-12-09
Decision Date2017-02-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169855519 K163460 000
00763000060428 K163460 000

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