The following data is part of a premarket notification filed by Drager Medical Ag & Co. Kgaa with the FDA for Infinity Acute Care System Workstation Neonatal Care.
| Device ID | K093632 |
| 510k Number | K093632 |
| Device Name: | INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | DRAGER MEDICAL AG & CO. KGAA 3135 Quarry Road Telford, PA 18969 |
| Contact | Joyce Kilroy |
| Correspondent | Joyce Kilroy DRAGER MEDICAL AG & CO. KGAA 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 | 2010-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048675250418 | K093632 | 000 |