Medtronic Patient Asistant

Detector And Alarm, Arrhythmia

Medtronic, Inc.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Medtronic Patient Asistant.

Pre-market Notification Details

Device IDK150117
510k NumberK150117
Device Name:Medtronic Patient Asistant
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 Received2015-01-20
Decision Date2015-05-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169571129 K150117 000
00643169476998 K150117 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.