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 | K093788 |
| 510k Number | K093788 |
| 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 DRIVE Andover, MA 01810 |
| Contact | Charles Morganson |
| Correspondent | Charles Morganson Draeger Medical Systems, Inc. 6 TECH DRIVE 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 | 2009-12-09 |
| Decision Date | 2010-03-08 |
| Summary: | summary |