Device Classification Name |
electrode, needle
|
510(k) Number |
K050194 |
Device Name |
AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES |
Applicant |
AXON SYSTEMS, INC. |
400-2200 OSER AVE. |
HAUPPAUGE,
NY
11788
|
|
Applicant Contact |
HOWARD BAILIN |
Correspondent |
AXON SYSTEMS, INC. |
400-2200 OSER AVE. |
HAUPPAUGE,
NY
11788
|
|
Correspondent Contact |
HOWARD BAILIN |
Regulation Number | 882.1350
|
Classification Product Code |
|
Date Received | 01/27/2005 |
Decision Date | 04/26/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|