The following data is part of a premarket notification filed by General Electric Medical Systems Information Techn with the FDA for Dash 3000/4000 Patient Monitor.
| Device ID | K001359 |
| 510k Number | K001359 |
| Device Name: | DASH 3000/4000 PATIENT MONITOR |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | David Wahlig |
| Correspondent | David Wahlig 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 | 2000-04-28 |
| Decision Date | 2000-07-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682115773 | K001359 | 000 |