510(k) K010402 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
SMOOTH-FLO CIRCUIT
| Applicant | Hudson Respiratory Care, Inc., Temecula CA, US |
| Decision | Substantially Equivalent, Mar 14, 2001 |
| Received | Feb 12, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010402
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.