The following data is part of a premarket notification filed by Scanditronix Wellhofer North America with the FDA for Dose 1.
| Device ID | K000209 |
| 510k Number | K000209 |
| Device Name: | DOSE 1 |
| Classification | Accelerator, Linear, Medical |
| Applicant | SCANDITRONIX WELLHOFER NORTH AMERICA 3111 STAGE POST DR., SUITE 105 Bartlett, TN 38133 |
| Contact | Chuck Lindley |
| Correspondent | Chuck Lindley SCANDITRONIX WELLHOFER NORTH AMERICA 3111 STAGE POST DR., SUITE 105 Bartlett, TN 38133 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-24 |
| Decision Date | 2000-08-18 |