BIO-PROBE TRANSDUCER (ADULT)

Probe, Blood-flow, Extravascular

MEDTRONIC INC.

The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Bio-probe Transducer (adult).

Pre-market Notification Details

Device IDK133903
510k NumberK133903
Device Name:BIO-PROBE TRANSDUCER (ADULT)
ClassificationProbe, Blood-flow, Extravascular
Applicant MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View,  MN  55112
ContactRahul Shah
CorrespondentRahul Shah
MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View,  MN  55112
Product CodeDPT  
CFR Regulation Number870.2120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-20
Decision Date2014-04-10
Summary:summary

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