Device Classification Name |
Electromyograph, Diagnostic
|
510(k) Number |
K024316 |
Device Name |
NIM-PRS |
Applicant |
MEDTRONIC XOMED, INC. |
6743 SOUTHPOINT DR. NORTH |
JACKSONVILLE,
FL
32216
|
|
Applicant Contact |
MARTIN SARGENT |
Correspondent |
CITECH |
5200 BUTLER PIKE |
PLYMOUTH MEETING,
PA
19462 -1298
|
|
Correspondent Contact |
ROBERT MOSENKIS |
Regulation Number | 890.1375
|
Classification Product Code |
|
Date Received | 12/26/2002 |
Decision Date | 01/06/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|