510(k) K152748 ยท FLL Continuous Measurement Thermometer
Braun Thermoscan PRO 6000 Ear Thermometer
| Applicant | Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc), Southborough MA, US |
| Decision | Substantially Equivalent, Mar 1, 2016 |
| Received | Sep 23, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152748
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 11, 2024 | Baxter Healthcare Corporation Braun Thermoscan PRO 6000 Ear Thermometer Open, Classified |
FLL | None listed |
| Jul 20, 2021 | Welch Allyn Inc Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body temperature for patients having ages ranging from normal weight (full term) newborn to geriatric adul Open, Classified |
FLL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.