The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Modification To Dash 3000/4000 Patient Monitor.
| Device ID | K033304 |
| 510k Number | K033304 |
| Device Name: | MODIFICATION TO DASH 3000/4000 PATIENT MONITOR |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Melissa Robinson |
| Correspondent | Melissa Robinson GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-14 |
| Decision Date | 2003-11-12 |
| Summary: | summary |