K172427 is an FDA 510(k) clearance for the AViTA Radar Thermo NT16 Series IR Thermometer. This device is classified as a Continuous Measurement Thermometer (Class II - Special Controls, product code FLL).
Submitted by Avita Corporation (New Taipei City, TW). The FDA issued a Cleared decision on April 19, 2018, 252 days after receiving the submission on August 10, 2017.
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 | K172427 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 2017 |
| Decision Date | April 19, 2018 |
| Days to Decision | 252 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. |