510(k) K820227 ยท CAF Nebulizer (Direct Patient Interface)
STER-O-DOSE
| Applicant | Inhalation Therapy Equipment, Co., Mchenry IL, US |
| Decision | Substantially Equivalent, Feb 23, 1982 |
| Received | Jan 27, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K820227
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 4, 2019 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Portex Unit Dose 5 ml Normal Saline (0.9%) Terminated |
CAF | None listed |
| Feb 4, 2019 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Portex Unit Dose 15 ml Normal Saline Terminated |
CAF | None listed |
| Feb 4, 2019 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Portex 5ml Normal Saline (0.9%) Unit Dose Terminated |
CAF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.