Myotronics-Noromed, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
7
Inspections
5
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K111687EMG SYSTEMSeptember 29, 2011
K040400MYO-TRODE SG DISPOSABLE ELECTRODEJuly 20, 2004
K031998MODEL J-5 MVO-MONITORJuly 24, 2003
K013399MODEL MES-9000/EMG SYSTEMNovember 13, 2001
K003287MODEL K7 EVALUATION DEVICENovember 6, 2000
K992694MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-ISeptember 10, 1999
K992439NORODYN 8000 SEMG SYSTEM, ND-8000August 13, 1999