The following data is part of a premarket notification filed by Siemens Medical Electronics with the FDA for Siemens Radiotom 904 & 904e Electrosurgery Unit.
| Device ID | K912070 |
| 510k Number | K912070 |
| Device Name: | SIEMENS RADIOTOM 904 & 904E ELECTROSURGERY UNIT |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SIEMENS MEDICAL ELECTRONICS 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Contact | Robert R Murfitt |
| Correspondent | Robert R Murfitt SIEMENS MEDICAL ELECTRONICS 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-10 |
| Decision Date | 1992-04-23 |