The following data is part of a premarket notification filed by Marquette Medical Systems, Inc. with the FDA for Dash 1000 Patient Monitor.
| Device ID | K970545 |
| 510k Number | K970545 |
| Device Name: | DASH 1000 PATIENT MONITOR |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | MARQUETTE MEDICAL SYSTEMS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Dianne Schmitz |
| Correspondent | Dianne Schmitz MARQUETTE MEDICAL SYSTEMS, INC. 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 | 1997-02-12 |
| Decision Date | 1997-05-08 |
| Summary: | summary |