510(k) K173280 ยท BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Neonatal ConchaSmart Breathing Circuits
| Applicant | Teleflexmedical, Inc., Morrisville NC, US |
| Decision | Substantially Equivalent, Aug 2, 2018 |
| Received | Oct 16, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173280
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 15, 2019 | Teleflex Medical Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column:
a) REF 870-07KIT
b) REF 870-09KIT
Product Usage:
The Neonatal ConchaSmart breathing cir Terminated |
BZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.