510(k) K000186 ยท MRN Apparatus, Nitric Oxide Delivery
DATEX-OHMEDA INOVENT DELIVERY SYSTEM
| Applicant | Datex-Ohmeda, Madison WI, US |
| Decision | Substantially Equivalent, Feb 10, 2000 |
| Received | Jan 14, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K000186
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 25, 2006 | INO Therapeutics, Inc. INOvent, Nitric Oxide Delivery System. Model Number 1605-9000-000 Terminated |
MRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.