The following data is part of a premarket notification filed by Draeger Medical Systems, Inc. with the FDA for Infinity Kappa Xlt.
| Device ID | K042904 |
| 510k Number | K042904 |
| Device Name: | INFINITY KAPPA XLT |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | Draeger Medical Systems, Inc. 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Contact | Penelope H Greco |
| Correspondent | Penelope H Greco Draeger Medical Systems, Inc. 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-21 |
| Decision Date | 2005-02-18 |
| Summary: | summary |