The following data is part of a premarket notification filed by Draeger Medical Systems, Inc. with the FDA for Infinity Acute Care System (iacs) Monitoring Solution.
| Device ID | K201764 |
| 510k Number | K201764 |
| Device Name: | Infinity Acute Care System (IACS) Monitoring Solution |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | Draeger Medical Systems, Inc. 6 Tech Dr. Andover, MA 01810 |
| Contact | Tom Hirte |
| Correspondent | Tom Hirte Draeger Medical Systems, Inc. 6 Tech Dr. Andover, MA 01810 |
| Product Code | MHX |
| Subsequent Product Code | BSZ |
| Subsequent Product Code | BTL |
| Subsequent Product Code | BZQ |
| Subsequent Product Code | CBK |
| Subsequent Product Code | CBQ |
| Subsequent Product Code | CBR |
| Subsequent Product Code | CBS |
| Subsequent Product Code | CCK |
| Subsequent Product Code | CCL |
| Subsequent Product Code | DPS |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DQE |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSA |
| Subsequent Product Code | DSB |
| Subsequent Product Code | DSF |
| Subsequent Product Code | DSI |
| Subsequent Product Code | DSK |
| Subsequent Product Code | DXN |
| Subsequent Product Code | &nb |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-29 |
| Decision Date | 2021-12-09 |