FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Infrared Forehead Thermometer
K Number: K202420
·
Decision Feb 25, 2021
Classifications
1
FEI Numbers
518
Registration Numbers
518
Same Product Code
795
Applicant Total
2
Review Days
185
Basic Information
- Device Name
- Infrared Forehead Thermometer
- K Number
- K202420
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2910
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Conmo Electronic Company Limited
- Date Received
- August 24, 2020
- Decision Date
- February 25, 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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Other Clearances by Conmo Electronic Company Limited
| K Number | Device Name | ||
|---|---|---|---|
| K202372 | Upper Arm Electronic Blood Pressure Monitor | Dec 30, 2020 | Substantially Equivalent |