NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM
FDA 510(k) clearance K082724 · decided 2008-12-16
Clearance details
- K-number
- K082724
- Device name
- NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM
- Applicant
- Newport Medical Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-09-17
- Decision date
- 2008-12-16
- Days to decision
- 90 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| V24-00400-29 cable, an accessory to the Newport HT50 ventilator. The V24-00400-29 cable is recall (Z-1041-2012) | Flight Medical Ltd. | 2012-02-21 |
| Newport HT50 Ventilator, Model # HT-50-H, HT50-HB, HT50-H1, and HT50-H1B Product Code: NOU recall (Z-2384-2011) | Newport Medical Instruments Inc | 2011-05-27 |