The following data is part of a premarket notification filed by Microsystem Controls with the FDA for Emg Report Generator.
Device ID | K844681 |
510k Number | K844681 |
Device Name: | EMG REPORT GENERATOR |
Classification | Device, Nerve Conduction Velocity Measurement |
Applicant | MICROSYSTEM CONTROLS 790 VEDADO WAY NE Atlanta, GA 30308 |
Contact | Gordon L Gibby |
Correspondent | Gordon L Gibby MICROSYSTEM CONTROLS 790 VEDADO WAY NE Atlanta, GA 30308 |
Product Code | JXE |
CFR Regulation Number | 882.1550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-30 |
Decision Date | 1985-02-26 |