T4 MONITOR STIMULATOR COMPUTER

Stimulator, Nerve, Battery-powered

REGIONAL MASTER CORP.

The following data is part of a premarket notification filed by Regional Master Corp. with the FDA for T4 Monitor Stimulator Computer.

Pre-market Notification Details

Device IDK853476
510k NumberK853476
Device Name:T4 MONITOR STIMULATOR COMPUTER
ClassificationStimulator, Nerve, Battery-powered
Applicant REGIONAL MASTER CORP. P.O. BOX 431832 Miami,  FL  33143
ContactMargarita Plaza
CorrespondentMargarita Plaza
REGIONAL MASTER CORP. P.O. BOX 431832 Miami,  FL  33143
Product CodeBXN  
CFR Regulation Number868.2775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-08-14
Decision Date1986-01-14

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