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 | K032149 |
510k Number | K032149 |
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 | Karen J Frischmeyer |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2003-07-14 |
Decision Date | 2003-09-09 |
Summary: | summary |