510(k) K132857 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
RESPIRATORY GAS HUMIDIFIER
| Applicant | Pacific Medico Co., Ltd., Bunkyo-Ku, Tokyo, JP |
| Decision | Substantially Equivalent, May 1, 2014 |
| Received | Sep 12, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K132857
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.