FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
K Number: K250878
·
Decision May 22, 2025
Classifications
1
FEI Numbers
518
Registration Numbers
518
Same Product Code
795
Applicant Total
3
Review Days
59
Basic Information
- Device Name
- YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
- K Number
- K250878
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2910
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Jiangsu Yuyue Medical Equipment & Supply Co., Ltd
- Date Received
- March 24, 2025
- Decision Date
- May 22, 2025
- Product Code
- FLL
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | FDA class 2 | General Hospital |
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