510(k) K082724 ยท CBK Ventilator, Continuous, Facility Use
NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM
| Applicant | Newport Medical Instruments, Inc., Costa Mesa CA, US |
| Decision | Substantially Equivalent, Dec 16, 2008 |
| Received | Sep 17, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082724
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 21, 2012 | Flight Medical Ltd. V24-00400-29 cable, an accessory to the Newport HT50 ventilator.
The V24-00400-29 cable is an accessory to the Newport HT50 ventilator intended to transfer the alarm signal from the ventilator to a n Terminated |
CBK | None listed |
| May 27, 2011 | Newport Medical Instruments Inc Newport HT50 Ventilator, Model # HT-50-H, HT50-HB, HT50-H1, and HT50-H1B
Product Code: NOU
The device is intended to provide continuous or intermittent mechanical ventilator support for the care of Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.