510(k) K941535 ยท BYD Condenser, Heat And Moisture (Artificial Nose)
TRACHEOLIFE
| Applicant | Mallinckrodt Medical, Argyle NY, US |
| Decision | Substantially Equivalent, Apr 15, 1994 |
| Received | Mar 30, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941535
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 16, 2021 | Covidien, LP Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO Open, Classified |
CAH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.