The following data is part of a premarket notification filed by Draeger Medical Systems, Inc. with the FDA for Infinity Delta And Kappa Series Monitors With Vf6 Modifications.
| Device ID | K060039 |
| 510k Number | K060039 |
| Device Name: | INFINITY DELTA AND KAPPA SERIES MONITORS WITH VF6 MODIFICATIONS |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | Draeger Medical Systems, Inc. 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Contact | Karen Iorio |
| Correspondent | Karen Iorio Draeger Medical Systems, Inc. 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-06 |
| Decision Date | 2006-04-12 |
| Summary: | summary |