Medtronic Commander Flex

System, Measurement, Blood-pressure, Non-invasive

Medtronic Care Management Services

The following data is part of a premarket notification filed by Medtronic Care Management Services with the FDA for Medtronic Commander Flex.

Pre-market Notification Details

Device IDK191745
510k NumberK191745
Device Name:Medtronic Commander Flex
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Medtronic Care Management Services 7980 Century Boulevard Chanhassan,  MN  55317
ContactGordon Nelson
CorrespondentCharmaine Sutton
The Tamarack Group - MPLS, LLC 2584 Upton Ave. So Minneapolis,  MN  55405
Product CodeDXN  
Subsequent Product CodeDQA
Subsequent Product CodeDRG
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-01
Decision Date2020-05-15

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