INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE
FDA 510(k) clearance K093632 · decided 2010-04-05
Clearance details
- K-number
- K093632
- Device name
- INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE
- Applicant
- Drager Medical AG & Co. Kgaa
- Decision
- Substantially Equivalent
- Date received
- 2009-11-23
- Decision date
- 2010-04-05
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Telford, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation. recall (Z-0827-2016) | Draeger Medical, Inc. | 2016-02-25 |
| Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilato recall (Z-0436-2016) | Draeger Medical, Inc. | 2015-12-23 |
| PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventila recall (Z-2343-2015) | Draeger Medical, Inc. | 2015-08-14 |
| Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infin recall (Z-1298-2014) | Draeger Medical Systems, Inc. | 2014-03-28 |