Device Classification Name |
device, biofeedback
|
510(k) Number |
K922838 |
Device Name |
NORODYN 2000 ELECTROMYOGRAPH |
Applicant |
NOROMED, INC. |
720 OLIVE WAY |
SUITE 800 |
SEATTLE,
WA
98101
|
|
Applicant Contact |
ADIB |
Correspondent |
NOROMED, INC. |
720 OLIVE WAY |
SUITE 800 |
SEATTLE,
WA
98101
|
|
Correspondent Contact |
ADIB |
Regulation Number | 882.5050
|
Classification Product Code |
|
Date Received | 06/12/1992 |
Decision Date | 09/22/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|