510(k) K001213 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60
| Applicant | Hudson Respiratory Care, Inc., Temecula CA, US |
| Decision | Substantially Equivalent, Nov 3, 2000 |
| Received | Apr 14, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001213
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.