NT 2000 LESIONING GENERATOR

Generator, Lesion, Radiofrequency

NEUROTHERM, INC.

The following data is part of a premarket notification filed by Neurotherm, Inc. with the FDA for Nt 2000 Lesioning Generator.

Pre-market Notification Details

Device IDK111576
510k NumberK111576
Device Name:NT 2000 LESIONING GENERATOR
ClassificationGenerator, Lesion, Radiofrequency
Applicant NEUROTHERM, INC. 200 Homer Ave Ashland,  MA  01721
ContactF. David Rothkopf
CorrespondentF. David Rothkopf
NEUROTHERM, INC. 200 Homer Ave Ashland,  MA  01721
Product CodeGXD  
CFR Regulation Number882.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-06
Decision Date2011-09-20
Summary:summary

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