510(k) K212965 ยท LHQ System, Telethermographic (Adjunctive Use)
Smile-100 System
| Applicant | Niramai Health Analytix Private Limited, Bangalore, IN |
| Decision | Substantially Equivalent, Mar 10, 2022 |
| Received | Sep 16, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212965
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.