510(k) K972371 ยท CAF Nebulizer (Direct Patient Interface)
ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR
| Applicant | Brasamerica Medical Equipment, Inc., Great Neck, NY, US |
| Decision | Substantially Equivalent, Aug 19, 1997 |
| Received | Jun 25, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972371
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.