Device Classification Name |
Electrode, Needle
|
510(k) Number |
K130136 |
Device Name |
DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES, |
Applicant |
TECHNOMED EUROPE |
AMERIKALAAN 71 |
MAASTRICHT AIRPORT,
NL
6199 AE
|
|
Applicant Contact |
PIERRE VREULS |
Correspondent |
TECHNOMED EUROPE |
AMERIKALAAN 71 |
MAASTRICHT AIRPORT,
NL
6199 AE
|
|
Correspondent Contact |
PIERRE VREULS |
Regulation Number | 882.1350
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/18/2013 |
Decision Date | 07/19/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|