EMG REPORT GENERATOR

Device, Nerve Conduction Velocity Measurement

MICROSYSTEM CONTROLS

The following data is part of a premarket notification filed by Microsystem Controls with the FDA for Emg Report Generator.

Pre-market Notification Details

Device IDK844681
510k NumberK844681
Device Name:EMG REPORT GENERATOR
ClassificationDevice, Nerve Conduction Velocity Measurement
Applicant MICROSYSTEM CONTROLS 790 VEDADO WAY NE Atlanta,  GA  30308
ContactGordon L Gibby
CorrespondentGordon L Gibby
MICROSYSTEM CONTROLS 790 VEDADO WAY NE Atlanta,  GA  30308
Product CodeJXE  
CFR Regulation Number882.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-11-30
Decision Date1985-02-26

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