510(k) K100285 ยท CAF Nebulizer (Direct Patient Interface)
LITETOUCH MASK
| Applicant | Respironics New Jersey, Inc., Parsippany NJ, US |
| Decision | Substantially Equivalent, Jun 29, 2010 |
| Received | Feb 1, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100285
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.