YUWELL infrared ear thermometer: YHT101, YHT200
FDA 510(k) clearance K203583 · decided 2021-05-20
Clearance details
- K-number
- K203583
- Device name
- YUWELL infrared ear thermometer: YHT101, YHT200
- Applicant
- Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-12-08
- Decision date
- 2021-05-20
- Days to decision
- 163 days
- Clearance type
- Traditional
- Product code
- FLL
- Device class
- 2
- Regulation number
- 880.2910
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Jiangsu, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.