Device Classification Name |
electrode, needle, diagnostic electromyograph
|
510(k) Number |
K990015 |
Device Name |
ELECTRODE NEEDLES |
Applicant |
TECHNOMED EUROPE |
STATIONSTRAAT 122 |
P.O. BOX 239 |
6191 BG BEEK,
NL
6191 BG
|
|
Applicant Contact |
HARRY KNUTH |
Correspondent |
TECHNOMED EUROPE |
STATIONSTRAAT 122 |
P.O. BOX 239 |
6191 BG BEEK,
NL
6191 BG
|
|
Correspondent Contact |
HARRY KNUTH |
Regulation Number | 890.1385
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/04/1999 |
Decision Date | 05/27/1999 |
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
|
|
|