The following data is part of a premarket notification filed by Somnus Medical Technologies, Inc. with the FDA for Somnus Model S2 Electrosurgical Generator.
| Device ID | K001438 |
| 510k Number | K001438 |
| Device Name: | SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SOMNUS MEDICAL TECHNOLOGIES, INC. 285 NORTH WOLFE RD. Sunnyvale, CA 94086 |
| Contact | Steven J Ojala, Ph.d |
| Correspondent | Steven J Ojala, Ph.d SOMNUS MEDICAL TECHNOLOGIES, INC. 285 NORTH WOLFE RD. Sunnyvale, CA 94086 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-08 |
| Decision Date | 2000-05-16 |