The following data is part of a premarket notification filed by Rita Medical Systems Inc with the FDA for Rita Model 1500x Electrosurgical Rf Generator.
| Device ID | K031257 |
| 510k Number | K031257 |
| Device Name: | RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | RITA MEDICAL SYSTEMS INC 967 N. SHORELINE BLVD. Mountain View, CA 94043 |
| Contact | Vicki Hacker |
| Correspondent | Charles Mack UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-04-21 |
| Decision Date | 2003-05-02 |
| Summary: | summary |