510(k) K181649 ยท NVP Holding Chambers, Direct Patient Interface
AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)
| Applicant | Trudell Medical International, London, CA |
| Decision | Substantially Equivalent, Jan 11, 2019 |
| Received | Jun 22, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181649
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 16, 2021 | Cardinal Health Inc. AEROCHAMBER PLS W/MASK LRG BLU
Item Number: 1496033 Open, Classified |
NVP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.