Device Classification Name |
Stimulator, Nerve, Transcutaneous, For Pain Relief
|
510(k) Number |
K890088 |
Device Name |
ACUDATA INDICATENS MODEL 5X |
Applicant |
ACUDATA SOFTWARE |
604 SARTORI DR. |
PETALUMA,
CA
94952
|
|
Applicant Contact |
JOEL ROSSEN |
Correspondent |
ACUDATA SOFTWARE |
604 SARTORI DR. |
PETALUMA,
CA
94952
|
|
Correspondent Contact |
JOEL ROSSEN |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 01/10/1989 |
Decision Date | 05/26/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|