510(k) K120635 ยท BTY Calculator, Predicted Values, Pulmonary Function
EASYONE PRO RESPIRATORY TESTING DEVICE
| Applicant | Ndd Medizitechnik AG, Andover MA, US |
| Decision | Substantially Equivalent, Sep 27, 2012 |
| Received | Mar 1, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120635
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.