POLYGRAM NET BIOFEEDBACK APPLICATION

Device, Biofeedback

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Polygram Net Biofeedback Application.

Pre-market Notification Details

Device IDK041244
510k NumberK041244
Device Name:POLYGRAM NET BIOFEEDBACK APPLICATION
ClassificationDevice, Biofeedback
Applicant MEDTRONIC VASCULAR 4000 LEXINGTON AVE., NORTH Shoreview,  MN  55126 -2893
ContactJulie Goode
CorrespondentJulie Goode
MEDTRONIC VASCULAR 4000 LEXINGTON AVE., NORTH Shoreview,  MN  55126 -2893
Product CodeHCC  
CFR Regulation Number882.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-05-11
Decision Date2004-08-12
Summary:summary

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