The following data is part of a premarket notification filed by Somnus Medical Technologies, Inc. with the FDA for Electrosurgical Generator, Model S1.
| Device ID | K000501 |
| 510k Number | K000501 |
| Device Name: | ELECTROSURGICAL GENERATOR, MODEL S1 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SOMNUS MEDICAL TECHNOLOGIES, INC. 285 NORTH WOLFE RD. Sunnyvale, CA 94086 |
| Contact | Steven J Ojala |
| Correspondent | Steven J Ojala SOMNUS MEDICAL TECHNOLOGIES, INC. 285 NORTH WOLFE RD. Sunnyvale, CA 94086 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-15 |
| Decision Date | 2000-03-17 |