The following data is part of a premarket notification filed by Surgical Navigation Technologies, Inc. with the FDA for Stealthstation System Digitizer Change.
| Device ID | K981686 |
| 510k Number | K981686 |
| Device Name: | STEALTHSTATION SYSTEM DIGITIZER CHANGE |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | SURGICAL NAVIGATION TECHNOLOGIES, INC. 530 COMPTON ST. Broomfield, CO 80020 |
| Contact | Roger White |
| Correspondent | Roger White SURGICAL NAVIGATION TECHNOLOGIES, INC. 530 COMPTON ST. Broomfield, CO 80020 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-13 |
| Decision Date | 1998-08-07 |
| Summary: | summary |