Infrared thermometer
FDA 510(k) clearance K221211 · decided 2022-09-27
Clearance details
- K-number
- K221211
- Device name
- Infrared thermometer
- Applicant
- Shenzhen Yolanda Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-04-27
- Decision date
- 2022-09-27
- Days to decision
- 153 days
- Clearance type
- Traditional
- Product code
- FLL
- Device class
- 2
- Regulation number
- 880.2910
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.