510(k) K173483 ยท DRN Device, Counter-Pulsating, External
Pure Flow External Counter-Pulsation Device
| Applicant | Xtreem Pulse, LLC, New York NY, US |
| Decision | Substantially Equivalent, May 30, 2018 |
| Received | Nov 13, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173483
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.