Device Classification Name |
electromyograph, diagnostic
|
510(k) Number |
K812715 |
Device Name |
TECA #TE 8 |
Applicant |
TECA, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
TECA, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 890.1375
|
Classification Product Code |
|
Date Received | 09/25/1981 |
Decision Date | 10/13/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|