510(k) K192713 ยท CAH Filter, Bacterial, Breathing-Circuit
Altera Filter and HME/Filter
| Applicant | Meditera Tibbi Malzeme San VE Tic AS, Izmir, TR |
| Decision | Substantially Equivalent, Mar 16, 2020 |
| Received | Sep 27, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192713
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 22, 2023 | S & MOHR AMERICA, S.A. DE C.V. abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF BC21087
abm Respiratory Care Standart Breathing Circuit with Face Mask - Child/Adult Small REF BC21088
abm Respiratory Car Open, Classified |
CAH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.