510(k) K961973 ยท CAF Nebulizer (Direct Patient Interface)
DHD ACE WITH MASK KIT
| Applicant | Dhd Diemolding Healthcare Div., Canastota NY, US |
| Decision | Substantially Equivalent, Aug 15, 1996 |
| Received | May 20, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961973
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2021 | Smiths Medical ASD Inc. ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from metered dose inhaler canisters and with mechanically ventilated patients. Terminated |
CAF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.