The following data is part of a premarket notification filed by Elekta Instrument Ab with the FDA for Elekta Microdrive, Model 916716.
| Device ID | K040979 |
| 510k Number | K040979 |
| Device Name: | ELEKTA MICRODRIVE, MODEL 916716 |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | ELEKTA INSTRUMENT AB KUNGSTENSGATAN 18 PO BOX 7593 Stockholm, SE S-103 93 |
| Contact | Anders Skoglund |
| Correspondent | Anders Skoglund ELEKTA INSTRUMENT AB KUNGSTENSGATAN 18 PO BOX 7593 Stockholm, SE S-103 93 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-15 |
| Decision Date | 2004-07-23 |
| Summary: | summary |