510(k) K000653 ยท MRN Apparatus, Nitric Oxide Delivery
AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001, AERONOX TRANSPORT TRANSPORT, MODEL P/N 360002
| Applicant | Pulmonox Medical Corp., Tofield, Alberta, CA |
| Decision | Substantially Equivalent, Aug 4, 2000 |
| Received | Feb 28, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000653
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.