The following data is part of a premarket notification filed by Draeger Medical Systems, Inc. with the FDA for Infinity Gateway Suite, Vf4.
| Device ID | K043549 |
| 510k Number | K043549 |
| Device Name: | INFINITY GATEWAY SUITE, VF4 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-23 |
| Decision Date | 2005-01-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049098095785 | K043549 | 000 |
| 04049098059749 | K043549 | 000 |
| 04048675445876 | K043549 | 000 |