510(k) K132017 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
HC550 RESPIRATORY HUMIDIFIER, ADULT VENTILATOR CIRCUIT
| Applicant | Fisher & Paykel Healthcare, Ltd., Manukau, NZ |
| Decision | Substantially Equivalent, Mar 25, 2014 |
| Received | Jul 1, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132017
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.