510(k) K163507 ยท PBZ Image Processing Device For Estimation Of External Blood Loss
Triton Sponge System
| Applicant | Gauss Surgical, Inc.,, Los Altos CA, US |
| Decision | Substantially Equivalent, Apr 25, 2017 |
| Received | Dec 14, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163507
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.