510(k) K201843
K201843 is an FDA 510(k) premarket notification submitted by Wenzhou Yosun Medical Technology Co.,Ltd for the device "Infrared ear and forehead thermometer, model YI-100". The FDA issued a decision of Substantially Equivalent on October 23, 2020. The device falls under product code FLL (Continuous Measurement Thermometer), a Class II device regulated under 21 CFR 880.2910. Wenzhou Yosun Medical Technology Co.,Ltd has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 23, 2020
- Date Received
- July 6, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Continuous Measurement Thermometer
- Device Class
- Class II
- Regulation Number
- 880.2910
- Review Panel
- HO
- Submission Type
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.