K100488 is an FDA 510(k) clearance for the IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081. This device is classified as a Continuous Measurement Thermometer (Class II - Special Controls, product code FLL).
Submitted by Shenzhen Dongdixin Technology Co., Ltd. (Nanshan District, Shenzhen, CN). The FDA issued a Cleared decision on July 22, 2010, 153 days after receiving the submission on February 19, 2010.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2910. A Continuous Measurement Thermometer Is A Clinical Electronic Thermometer Indicated To Measure The Body Or Skin Temperature Of A Person Continuously Or In Specified Intervals. Under This Regulation, This Product Code Represents Non-exempt Devices. For More Information, See 90 Fr 25889, Available At Https://www.govinfo.gov/content/pkg/fr-2025-06-18/pdf/2025-11207.pdf..
| 510(k) Number | K100488 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 2010 |
| Decision Date | July 22, 2010 |
| Days to Decision | 153 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FLL — Continuous Measurement Thermometer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2910 |
| Definition | A Continuous Measurement Thermometer Is A Clinical Electronic Thermometer Indicated To Measure The Body Or Skin Temperature Of A Person Continuously Or In Specified Intervals. Under This Regulation, This Product Code Represents Non-exempt Devices. For More Information, See 90 Fr 25889, Available At Https://www.govinfo.gov/content/pkg/fr-2025-06-18/pdf/2025-11207.pdf. |