The following data is part of a premarket notification filed by Scanditronix, Inc. with the FDA for Rfa A-300.
| Device ID | K934303 |
| 510k Number | K934303 |
| Device Name: | RFA A-300 |
| Classification | Accelerator, Linear, Medical |
| Applicant | SCANDITRONIX, INC. HUSBYBORG, S-752 29 UPPSALA Sweden, SE |
| Contact | Lennart Ward |
| Correspondent | Lennart Ward SCANDITRONIX, INC. HUSBYBORG, S-752 29 UPPSALA Sweden, SE |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-01 |
| Decision Date | 1994-08-09 |