510(k) K172388 ยท BWF Spirometer, Therapeutic (Incentive)
VPOD ITPR
| Applicant | Advanced Circulatory System, A Wholly Owned Subsidiary OF, Roseville MN, US |
| Decision | Substantially Equivalent, Dec 22, 2017 |
| Received | Aug 8, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172388
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.