STIMUPLEX HNS-11

Stimulator, Nerve, Battery-powered

STOCKERT GMBH

The following data is part of a premarket notification filed by Stockert Gmbh with the FDA for Stimuplex Hns-11.

Pre-market Notification Details

Device IDK003983
510k NumberK003983
Device Name:STIMUPLEX HNS-11
ClassificationStimulator, Nerve, Battery-powered
Applicant STOCKERT GMBH BOTZINGER STRABE 72 Freiburg,  DE D-79111
ContactDominika Schuler
CorrespondentDominika Schuler
STOCKERT GMBH BOTZINGER STRABE 72 Freiburg,  DE D-79111
Product CodeBXN  
CFR Regulation Number868.2775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-12-26
Decision Date2001-06-06

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