Patient Assistant Model PA97000

Detector And Alarm, Arrhythmia

Medtronic, Inc

The following data is part of a premarket notification filed by Medtronic, Inc with the FDA for Patient Assistant Model Pa97000.

Pre-market Notification Details

Device IDK190574
510k NumberK190574
Device Name:Patient Assistant Model PA97000
ClassificationDetector And Alarm, Arrhythmia
Applicant Medtronic, Inc 8200 Coral Sea Street NE Mounds View,  MN  55112
ContactCheryl Swanson
CorrespondentCheryl Swanson
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 Received2019-03-06
Decision Date2019-09-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00763000180904 K190574 000

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