510(k) K101136 ยท NVP Holding Chambers, Direct Patient Interface
FISIO CHAMBER SPACE
| Applicant | Koo (Shanghai) Industries Co., Ltd., Bonita Springs FL, US |
| Decision | Substantially Equivalent, Jan 28, 2011 |
| Received | Apr 22, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101136
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.