510(k) K133051 ยท BZC Calculator, Pulmonary Function Data
PULMONE MINIBOX PFT TM
| Applicant | Pulmone Advanced Medical Devices, Ltd., Gaithersburg MD, US |
| Decision | Substantially Equivalent, May 2, 2014 |
| Received | Sep 27, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133051
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.