Infrared Forehead Thermometer
FDA 510(k) clearance K220084 · decided 2022-09-12
Clearance details
- K-number
- K220084
- Device name
- Infrared Forehead Thermometer
- Applicant
- Qingdao Yasee Medical Device Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-01-10
- Decision date
- 2022-09-12
- Days to decision
- 245 days
- Clearance type
- Traditional
- Product code
- FLL
- Device class
- 2
- Regulation number
- 880.2910
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Qingdao, CN
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
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