510(k) K992133 ยท CBK Ventilator, Continuous, Facility Use
NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1, NEWPORT HT50 VENTIL
| Applicant | Newport Medical Instruments, Inc., Costa Mesa CA, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Aug 4, 2000 |
| Received | Jun 23, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992133
| 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 26, 2011 | Newport Medical Instruments Inc Newport HT50 Ventilator. Model #HT50 H1-B
The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Terminated |
CBK | None listed |
| May 26, 2011 | Newport Medical Instruments Inc Newport HT50 Ventilator.
Model No. HT50-H, HT50-HB, HT50-H1, and HT50-H1B.
The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who Terminated |
CBK | None listed |
| Sep 19, 2007 | Newport Medical Instruments Inc Newport HT50 Ventilator (all Models) Terminated |
CBK | None listed |
| Aug 17, 2005 | Newport Medical Instruments Inc Newport HT50 All Purpose Ventilator Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.