NOVAMETRIX MODEL 200 MAGSTIM

Stimulator, Electrical, Evoked Response

NOVAMETRIX MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Novametrix Medical Systems, Inc. with the FDA for Novametrix Model 200 Magstim.

Pre-market Notification Details

Device IDK871338
510k NumberK871338
Device Name:NOVAMETRIX MODEL 200 MAGSTIM
ClassificationStimulator, Electrical, Evoked Response
Applicant NOVAMETRIX MEDICAL SYSTEMS, INC. 45 WEST ST. SUITE 2 Attleboro,  MA  02703
ContactJames R Veale
CorrespondentJames R Veale
NOVAMETRIX MEDICAL SYSTEMS, INC. 45 WEST ST. SUITE 2 Attleboro,  MA  02703
Product CodeGWF  
CFR Regulation Number882.1870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-04-03
Decision Date1987-08-04

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