The following data is part of a premarket notification filed by General Electric Medical Systems Information Techn with the FDA for Solar 8000m System.
| Device ID | K012467 |
| 510k Number | K012467 |
| Device Name: | SOLAR 8000M SYSTEM |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Karen Webb |
| Correspondent | Karen Webb GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-01 |
| Decision Date | 2002-02-11 |
| Summary: | summary |