NEWPORT E360 VENTILATOR
FDA 510(k) clearance K053502 · decided 2006-01-10
Clearance details
- K-number
- K053502
- Device name
- NEWPORT E360 VENTILATOR
- Applicant
- Newport Medical Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-12-16
- Decision date
- 2006-01-10
- Days to decision
- 25 days
- Clearance type
- Special
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Costa Mesa, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Newport e360 Ventilator, Model Number: e360 The e360 Ventilator System is intended to prov recall (Z-2468-2011) | Newport Medical Instruments Inc | 2011-06-08 |
| Newport e360 Ventilator The e360 Ventilator System is intended to provide continuous (endo recall (Z-1617-2010) | Newport Medical Instruments Inc | 2010-05-19 |
| Newport e360 Ventilator, Rx only. The e360 Ventilator System is intended to provide contin recall (Z-2029-2009) | Newport Medical Instruments Inc | 2009-09-04 |