510(k) K070490 ยท BWF Spirometer, Therapeutic (Incentive)
CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR)
| Applicant | Advanced Circulatory Systems, Inc., Bonita Springs FL, US |
| Decision | Substantially Equivalent, Jun 20, 2007 |
| Received | Feb 20, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070490
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.