510(k) K061901 ยท MRN Apparatus, Nitric Oxide Delivery
INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003
| Applicant | Ino Therapeutics, Middleton WI, US |
| Decision | Substantially Equivalent, Dec 14, 2006 |
| Received | Jul 5, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061901
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 13, 2022 | Mallinckrodt, LLC. INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of n Open, Classified |
MRN | None listed |
| Jan 11, 2012 | Ino Therapeutics INOmax DS (Delivery System) Model 10003 & 10007.
The INOMAX DS Delivery System delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in Terminated |
MRN | None listed |
| Aug 13, 2010 | Ikaria Holdings Ikaria INOMAX DS Drug Delivery System, model 10003. Ikaria 6 Route 173, Clinton, NJ 08809 USA.
The INOMAX DS Delivery System delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspi Terminated |
MRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.