The following data is part of a premarket notification filed by Best Medical Canada Ltd. with the FDA for Portable Dosimeter Dose Verification System, Model Td-rd-90.
| Device ID | K092285 |
| 510k Number | K092285 |
| Device Name: | PORTABLE DOSIMETER DOSE VERIFICATION SYSTEM, MODEL TD-RD-90 |
| Classification | Accelerator, Linear, Medical |
| Applicant | BEST MEDICAL CANADA LTD. 413 MARCH ROAD Ottawa, Ontario, CA K2k 034 |
| Contact | Mary Herbert |
| Correspondent | Mary Herbert BEST MEDICAL CANADA LTD. 413 MARCH ROAD Ottawa, Ontario, CA K2k 034 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-29 |
| Decision Date | 2009-08-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00754014600090 | K092285 | 000 |
| 07540146000098 | K092285 | 000 |