510(k) K162767 ยท LHQ System, Telethermographic (Adjunctive Use)
Sentinel BreastScan II System
| Applicant | First Sense Medical, LLC, Pontiac MI, US |
| Decision | Substantially Equivalent, Jan 9, 2017 |
| Received | Sep 30, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K162767
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.