510(k) K212598 ยท FLL Continuous Measurement Thermometer
iHealth infrared Ear thermometer PT5
| Applicant | Andon Health Co, Ltd., Tianjin, CN |
| Decision | Substantially Equivalent, Jan 28, 2022 |
| Received | Aug 16, 2021 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K212598
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.