The following data is part of a premarket notification filed by Elekta Instrument Ab with the FDA for Accessories To The Stereotactic Body Fram.
| Device ID | K970291 |
| 510k Number | K970291 |
| Device Name: | ACCESSORIES TO THE STEREOTACTIC BODY FRAM |
| Classification | Accelerator, Linear, Medical |
| Applicant | ELEKTA INSTRUMENT AB ST. LARSGATAN 8 Linkoping, SE S-582 24 |
| Contact | Sverker Glans |
| Correspondent | Sverker Glans ELEKTA INSTRUMENT AB ST. LARSGATAN 8 Linkoping, SE S-582 24 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-24 |
| Decision Date | 1997-04-24 |
| Summary: | summary |