510(k) K131686 ยท MRN Apparatus, Nitric Oxide Delivery
INOMAX DSIR (DELIVERY SYSTEM)
| Applicant | Ino Therapeutics/Ikaria, Madison WI, US |
| Decision | Substantially Equivalent, Nov 29, 2013 |
| Received | Jun 10, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131686
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 9, 2018 | INO therapeutics LLC/dba ikaria Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System.
Product Usage;
Device Classification: The INOmeter is an accessory to the nitric oxide delivery device which is used for the deliver Terminated |
MRN | None listed |
| Nov 21, 2016 | INO Therapeutics (dba Ikaria) Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers INOMAX (nitric oxide for inhalation).
The INOmax DSIR uses a dual-channel design to ensure the safe delivery of Terminated |
MRN | None listed |
| Dec 12, 2014 | INO Therapeutics (dba Ikaria) INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO Terminated |
MRN | None listed |
| May 2, 2014 | INO Therapeutics (dba Ikaria) INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous mo Terminated |
MRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.