510(k) K003626 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
DEVILBISS HUMIDIFIER
| Applicant | Sunrise Medical Hhg, Inc., Somerset PA, US |
| Decision | Substantially Equivalent, May 4, 2001 |
| Received | Nov 24, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003626
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.