The following data is part of a premarket notification filed by Somnus Medical Technologies, Inc. with the FDA for Somnus Model 225 Electro Surgical Generator (model 225).
| Device ID | K963772 |
| 510k Number | K963772 |
| Device Name: | SOMNUS MODEL 225 ELECTRO SURGICAL GENERATOR (MODEL 225) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SOMNUS MEDICAL TECHNOLOGIES, INC. 995 BENECIA AVE. Sunnyvale, CA 94086 |
| Contact | Eva Conner |
| Correspondent | Eva Conner SOMNUS MEDICAL TECHNOLOGIES, INC. 995 BENECIA AVE. 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 | 1996-09-19 |
| Decision Date | 1996-10-23 |
| Summary: | summary |