The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Monarch System.
| Device ID | K911051 |
| 510k Number | K911051 |
| Device Name: | MONARCH SYSTEM |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Contact | Jack P Douglas |
| Correspondent | Jack P Douglas BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-08 |
| Decision Date | 1991-08-22 |