The following data is part of a premarket notification filed by Thomson & Nielsen Electronics, Ltd. with the FDA for Mosfet Autosense Wireless.
| Device ID | K032725 |
| 510k Number | K032725 |
| Device Name: | MOSFET AUTOSENSE WIRELESS |
| Classification | Accelerator, Linear, Medical |
| Applicant | THOMSON & NIELSEN ELECTRONICS, LTD. 25-B NORTHSIDE RD. Ottawa, Ontario, CA K2h 8s1 |
| Contact | Mary Herbert |
| Correspondent | Mary Herbert 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 | 2003-09-03 |
| Decision Date | 2003-10-03 |