K191283 is an FDA 510(k) clearance for the Infrared Thermometer, Breeze model. This device is classified as a Continuous Measurement Thermometer (Class II - Special Controls, product code FLL).
Submitted by Suzhou Melodicare Medical Technology Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on October 18, 2019, 158 days after receiving the submission on May 13, 2019.
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 | K191283 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2019 |
| Decision Date | October 18, 2019 |
| Days to Decision | 158 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. |