The following data is part of a premarket notification filed by Draeger Medical Ag & Co. Kg with the FDA for Infinity Acute Care System Workstation Critical Care.
| Device ID | K093633 |
| 510k Number | K093633 |
| Device Name: | INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | DRAEGER MEDICAL AG & CO. KG 3135 Quarry Road Telford, PA 18969 |
| Contact | Joyce Kilroy |
| Correspondent | Joyce Kilroy DRAEGER MEDICAL AG & CO. KG 3135 Quarry Road Telford, PA 18969 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-23 |
| Decision Date | 2010-03-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048675042266 | K093633 | 000 |
| 04048675421627 | K093633 | 000 |