510(k) K903083 ยท BZO Set, Tubing And Support, Ventilator (W Harness)
NEONATAL VENTILATOR CIRCUIT
| Applicant | Hudson Respiratory Care, Inc., Temecula CA, US |
| Decision | Substantially Equivalent, Dec 27, 1990 |
| Received | Jul 12, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K903083
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 21, 2026 | Medline Industries, LP Medline breathing circuits labeled as:
1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, Medline Product Number/SKU HUD78007 (Teleflex Product Number/SKU 780-07);
2) HUDSON RCI, DBM-CIRCUIT,VENT,NEONAT Open, Classified |
BZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.