The following data is part of a premarket notification filed by Elekta Instrument Ab with the FDA for Elekta Leksell Stereotactic System With Mr Post Kit.
| Device ID | K031999 |
| 510k Number | K031999 |
| Device Name: | ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | ELEKTA INSTRUMENT AB BIRGER JARLSGATAN 53 Stockholm, SE S-103-93 |
| Contact | Peter Lowendahl |
| Correspondent | Peter Lowendahl ELEKTA INSTRUMENT AB BIRGER JARLSGATAN 53 Stockholm, SE S-103-93 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-27 |
| Decision Date | 2003-07-25 |