LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit

Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection)

Medtronic, Inc.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Linq Ii Insertable Cardiac Monitor, Linq Mobile Manager, Device Command Library, Instrument Command Library, Linq Tool Kit.

Pre-market Notification Details

Device IDK200795
510k NumberK200795
Device Name:LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit
ClassificationRecorder, Event, Implantable Cardiac, (with Arrhythmia Detection)
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 CodeMXD  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-26
Decision Date2020-07-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00763000162191 K200795 000
00763000162191 K200795 000
00763000060374 K200795 000
00763000162191 K200795 000
00763000060374 K200795 000
00763000162191 K200795 000
00763000060374 K200795 000
00763000162191 K200795 000
00763000060374 K200795 000
00763000162191 K200795 000
00763000060374 K200795 000
00763000162191 K200795 000
00763000060374 K200795 000
00763000162191 K200795 000
00763000060374 K200795 000
00763000162191 K200795 000
00763000060374 K200795 000
00763000162191 K200795 000
00763000060374 K200795 000
00763000162191 K200795 000
00763000060374 K200795 000
00763000162191 K200795 000
00763000060374 K200795 000
00763000162191 K200795 000
00763000060374 K200795 000
00763000060374 K200795 000

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