The following data is part of a premarket notification filed by Elekta Instrument Ab with the FDA for Leksell Viewscope, Leksell Surgiscope, Leksell Freehand.
| Device ID | K973684 |
| 510k Number | K973684 |
| Device Name: | LEKSELL VIEWSCOPE, LEKSELL SURGISCOPE, LEKSELL FREEHAND |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | ELEKTA INSTRUMENT AB 18140 SMOKESIGNAL DR. San Diego, CA 92127 |
| Contact | Carol L Patterson |
| Correspondent | Carol L Patterson ELEKTA INSTRUMENT AB 18140 SMOKESIGNAL DR. San Diego, CA 92127 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-26 |
| Decision Date | 1998-03-31 |
| Summary: | summary |