The following data is part of a premarket notification filed by Draeger Medical Sytems, Inc. with the FDA for Infinity Delta, Infinity Delta Xl, Infinity Kappa.
| Device ID | K152407 |
| 510k Number | K152407 |
| Device Name: | Infinity Delta, Infinity Delta XL, Infinity Kappa |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | Draeger Medical Sytems, Inc. 6 Tech Drive Andover, MA 01810 |
| Contact | Beth Zis |
| Correspondent | Beth Zis Draeger Medical Sytems, Inc. 6 Tech Drive Andover, MA 01810 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-25 |
| Decision Date | 2015-09-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049098054546 | K152407 | 000 |