The following data is part of a premarket notification filed by Nomos Corp. with the FDA for Gnomos Stereotactic System W/ Noninvasive Fixation.
| Device ID | K931991 |
| 510k Number | K931991 |
| Device Name: | GNOMOS STEREOTACTIC SYSTEM W/ NONINVASIVE FIXATION |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | NOMOS CORP. 7800 RED RD. SUITE 330-D South Miami, FL 33143 |
| Contact | Marvin L Sussman |
| Correspondent | Marvin L Sussman NOMOS CORP. 7800 RED RD. SUITE 330-D South Miami, FL 33143 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-22 |
| Decision Date | 1993-08-20 |