The following data is part of a premarket notification filed by Somnus Medical Technologies, Inc. with the FDA for Somnus Model 615 Electrosurgical Generator(model 615).
| Device ID | K970576 |
| 510k Number | K970576 |
| Device Name: | SOMNUS MODEL 615 ELECTROSURGICAL GENERATOR(MODEL 615) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SOMNUS MEDICAL TECHNOLOGIES, INC. 285 NORTH WOLFE RD. Sunnyvale, CA 94086 |
| Contact | Eve A Conner, Ph.d. |
| Correspondent | Eve A Conner, 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-13 |
| Decision Date | 1997-04-09 |
| Summary: | summary |