Device Classification Name |
Stimulator, Nerve, Transcutaneous, For Pain Relief
|
510(k) Number |
K002297 |
Device Name |
YORAMED, MODEL T-202 |
Applicant |
UNITED YORAM DISTRIBUTORS, INC. |
602 DEGRAW ST. |
BROOKLYN,
NY
11217
|
|
Applicant Contact |
MORRIS MIZRAHI |
Correspondent |
UNITED YORAM DISTRIBUTORS, INC. |
602 DEGRAW ST. |
BROOKLYN,
NY
11217
|
|
Correspondent Contact |
MORRIS MIZRAHI |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 07/28/2000 |
Decision Date | 03/15/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|