Reveal LINQ

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.

Pre-market Notification Details

Device IDK160689
510k NumberK160689
Device Name:Reveal LINQ
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-03-11
Decision Date2016-04-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169732216 K160689 000

Trademark Results [Reveal LINQ]

Mark Image

Registration | Serial
Company
Trademark
Application Date
REVEAL LINQ
REVEAL LINQ
85481814 4689006 Live/Registered
Medtronic, Inc.
2011-11-28

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