510(k) K100488 ยท FLL Continuous Measurement Thermometer
IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081
| Applicant | Shenzhen Dongdixin Technology Co., Ltd., Nanshan District, Shenzhen, CN |
| Decision | Substantially Equivalent, Jul 22, 2010 |
| Received | Feb 19, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100488
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 22, 2018 | Philips Consumer Lifestyle Philips Avent Smart Ear Thermometer (SCH740), Philips Ear Thermometer (DL8740) Terminated |
FLL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.