The following data is part of a premarket notification filed by Elekta Instruments, Inc. with the FDA for Leksell Neuro Generator And Accessories.
| Device ID | K941823 |
| 510k Number | K941823 |
| Device Name: | LEKSELL NEURO GENERATOR AND ACCESSORIES |
| Classification | Generator, Lesion, Radiofrequency |
| Applicant | ELEKTA INSTRUMENTS, INC. 8 EXECUTIVE PARK WEST Atlanta, GA 30329 |
| Contact | Sverker Glans |
| Correspondent | Sverker Glans ELEKTA INSTRUMENTS, INC. 8 EXECUTIVE PARK WEST Atlanta, GA 30329 |
| Product Code | GXD |
| CFR Regulation Number | 882.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-13 |
| Decision Date | 1996-03-22 |