510(k) K971808 ยท CAF Nebulizer (Direct Patient Interface)
SPACE CHAMBER FOR MODEL NUMBER AND ACCESSORIES
| Applicant | Monarch Medical, Blaine WA, US |
| Decision | Substantially Equivalent, Sep 26, 1997 |
| Received | May 15, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971808
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.