The following data is part of a premarket notification filed by Carl Zeiss, Inc. with the FDA for Surgical Microscope Navigator (smn) System/surgical Tool Navigator (stn) System.
| Device ID | K965139 |
| 510k Number | K965139 |
| Device Name: | SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | CARL ZEISS, INC. ONE ZEISS DR. Thornwood, NY 10594 |
| Contact | Kenneth M Nicoll |
| Correspondent | Kenneth M Nicoll CARL ZEISS, INC. ONE ZEISS DR. Thornwood, NY 10594 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-23 |
| Decision Date | 1997-04-23 |
| Summary: | summary |