The following data is part of a premarket notification filed by Elekta Instrument Ab with the FDA for Stereotactic Body Frame.
| Device ID | K960338 |
| 510k Number | K960338 |
| Device Name: | STEREOTACTIC BODY FRAME |
| Classification | Accelerator, Linear, Medical |
| Applicant | ELEKTA INSTRUMENT AB 181 40 SMOKESIGNAL DR. San Diego, CA 92127 |
| Contact | Carol Patterson |
| Correspondent | Carol Patterson ELEKTA INSTRUMENT AB 181 40 SMOKESIGNAL DR. San Diego, CA 92127 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-24 |
| Decision Date | 1996-04-23 |
| Summary: | summary |