Device Classification Name |
Electromyograph, Diagnostic
|
510(k) Number |
K102610 |
Device Name |
FOCUS EMG DEVICE |
Applicant |
TELEEMG, LLC USA |
65 ARLINGTON ROAD |
WOBURN,
MA
01801
|
|
Applicant Contact |
JOE F JABRE, M.D. |
Correspondent |
TELEEMG, LLC USA |
65 ARLINGTON ROAD |
WOBURN,
MA
01801
|
|
Correspondent Contact |
JOE F JABRE, M.D. |
Regulation Number | 890.1375
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/10/2010 |
Decision Date | 03/04/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|