GS 3000

Stimulator, Muscle, Powered

EMSI

The following data is part of a premarket notification filed by Emsi with the FDA for Gs 3000.

Pre-market Notification Details

Device IDK102202
510k NumberK102202
Device Name:GS 3000
ClassificationStimulator, Muscle, Powered
Applicant EMSI 901 KING STREET SUITE 200 Alexandria,  VA  22314
ContactCherita James
CorrespondentCherita James
EMSI 901 KING STREET SUITE 200 Alexandria,  VA  22314
Product CodeIPF  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-08-04
Decision Date2010-11-23
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.