Level Sensor, Level Sensor Tape

Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass

Medtronic, Inc

The following data is part of a premarket notification filed by Medtronic, Inc with the FDA for Level Sensor, Level Sensor Tape.

Pre-market Notification Details

Device IDK150530
510k NumberK150530
Device Name:Level Sensor, Level Sensor Tape
ClassificationMonitor And/or Control, Level Sensing, Cardiopulmonary Bypass
Applicant Medtronic, Inc 7611 Northland Drive Minneapolis,  MN  55428
ContactRahul Shah
CorrespondentRahul Shah
Medtronic, Inc 7611 Northland Drive Minneapolis,  MN  55428
Product CodeDTW  
CFR Regulation Number870.4340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-03-02
Decision Date2015-05-08
Summary:summary

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