510(k) K091428 ยท BTY Calculator, Predicted Values, Pulmonary Function
EASYONE PRO RESPIRATORY ANALYSIS SYSTEM
| Applicant | Ndd Medizitechnik AG, Andover MA, US |
| Decision | Substantially Equivalent, Jan 27, 2010 |
| Received | May 14, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091428
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.