INSPIRATION VENTILATOR SYSTEM
FDA 510(k) clearance K051550 · decided 2005-07-12
Clearance details
- K-number
- K051550
- Device name
- INSPIRATION VENTILATOR SYSTEM
- Applicant
- eVent Medical, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2005-06-13
- Decision date
- 2005-07-12
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Galway, IE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Hospira Power cord use on Symbiq One-Channel infuser and Symbiq Two-Channel infuser. Power recall (Z-1596-2011) | Hospira Inc | 2011-03-08 |