FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Non-contact Electronic Forehead Infrared Thermometer
K Number: K201582
·
Decision Jan 15, 2021
Classifications
1
FEI Numbers
518
Registration Numbers
518
Same Product Code
795
Applicant Total
1
Review Days
218
Basic Information
- Device Name
- Non-contact Electronic Forehead Infrared Thermometer
- K Number
- K201582
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2910
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.
- Date Received
- June 11, 2020
- Decision Date
- January 15, 2021
- 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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