510(k) K002153 ยท CAF Nebulizer (Direct Patient Interface)
ULTRASONIC NEBULIZER, MODEL NE-520
| Applicant | Medisana USA, Inc., Bonita Springs FL, US |
| Decision | Substantially Equivalent, Mar 13, 2001 |
| Received | Jul 17, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002153
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.