The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for 12 Rl Algorithm.
| Device ID | K060307 |
| 510k Number | K060307 |
| Device Name: | 12 RL ALGORITHM |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Patrick Zielinski |
| Correspondent | Patrick Zielinski GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-07 |
| Decision Date | 2006-08-04 |
| Summary: | summary |