510(k) K970035 ยท CAF Nebulizer (Direct Patient Interface)
JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009
| Applicant | Graham-Field, Inc., Great Neck, NY, US |
| Decision | Substantially Equivalent, Apr 1, 1997 |
| Received | Jan 3, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970035
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.