510(k) K162562 ยท DWJ System, Thermal Regulating
OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY
| Applicant | Bcg Medical, LLC, San Diego CA, US |
| Decision | Substantially Equivalent, Mar 17, 2017 |
| Received | Sep 14, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162562
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.