ANSiStim-PP

Stimulator, Electro-acupuncture

DyAnsys Inc

The following data is part of a premarket notification filed by Dyansys Inc with the FDA for Ansistim-pp.

Pre-market Notification Details

Device IDK170391
510k NumberK170391
Device Name:ANSiStim-PP
ClassificationStimulator, Electro-acupuncture
Applicant DyAnsys Inc 300, North Bayshore Boulevard San Mateo,  CA  94401
ContactSrini Nageshwar
CorrespondentSrini Nageshwar
DyAnsys Inc 300, North BayShore Boulevard San Mateo,  CA  94401
Product CodeBWK  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-02-08
Decision Date2017-03-09
Summary:summary

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