510(k) K003665 ยท MRO Apparatus, Nitric Oxide, Backup Delivery
FADASSI MEDICAL FM-1 NO BLENDER
| Applicant | Fadasis Medical, Inc., Middleton WI, US |
| Decision | Substantially Equivalent, Feb 23, 2001 |
| Received | Nov 28, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003665
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.