The following data is part of a premarket notification filed by Thomson & Nielsen Electronics, Ltd. with the FDA for Mosfet Autosense, Model Tn-rd-60.
| Device ID | K013279 |
| 510k Number | K013279 |
| Device Name: | MOSFET AUTOSENSE, MODEL TN-RD-60 |
| Classification | Accelerator, Linear, Medical |
| Applicant | THOMSON & NIELSEN ELECTRONICS, LTD. 25-B NORTHSIDE RD. Ottawa, Ontario, CA K2h 8s1 |
| Contact | Norma Thomson |
| Correspondent | Norma Thomson THOMSON & NIELSEN ELECTRONICS, LTD. 25-B NORTHSIDE RD. Ottawa, Ontario, CA K2h 8s1 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-02 |
| Decision Date | 2001-10-18 |