The following data is part of a premarket notification filed by Draeger Medical Systems, Inc. with the FDA for Infinity M300.
| Device ID | K200859 |
| 510k Number | K200859 |
| Device Name: | Infinity M300 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | Draeger Medical Systems, Inc. 6 Tech Dr. Andover, MA 01810 |
| Contact | Thomas Ostrowski |
| Correspondent | Thomas Ostrowski Draeger Medical Systems, Inc. 6 Tech Dr. Andover, MA 01810 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-01 |
| Decision Date | 2020-08-28 |