Device Classification Name |
accelerator, linear, medical
|
510(k) Number |
K013279 |
Device Name |
MOSFET AUTOSENSE, MODEL TN-RD-60 |
Applicant |
THOMSON & NIELSEN ELECTRONICS, LTD. |
25-B NORTHSIDE RD. |
OTTAWA, ONTARIO,
CA
K2H 8S1
|
|
Applicant Contact |
NORMA THOMSON |
Correspondent |
THOMSON & NIELSEN ELECTRONICS, LTD. |
25-B NORTHSIDE RD. |
OTTAWA, ONTARIO,
CA
K2H 8S1
|
|
Correspondent Contact |
NORMA THOMSON |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 10/02/2001 |
Decision Date | 10/18/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|