510(k) K161933 · FLL Continuous Measurement Thermometer
The Braun ThermoScan® 3 High Speed Compact Ear Thermometer
| Applicant | Kaz USA, Inc., A Helen of Troy Company, Marlborough MA, US |
| Decision | Substantially Equivalent, Aug 16, 2016 |
| Received | Jul 14, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161933
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.