The following data is part of a premarket notification filed by Draeger Medical Systems, Inc. with the FDA for Infinity Gamma / Gammaxl, Infinity Vista.
| Device ID | K053484 |
| 510k Number | K053484 |
| Device Name: | INFINITY GAMMA / GAMMAXL, INFINITY VISTA |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | Draeger Medical Systems, Inc. 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Contact | Karen A Lorio |
| Correspondent | Karen A Lorio 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 | 2005-12-15 |
| Decision Date | 2006-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049098049849 | K053484 | 000 |
| 04049098004022 | K053484 | 000 |
| 04049098003865 | K053484 | 000 |