FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C
K Number: K203332
·
Decision Feb 25, 2021
Classifications
1
FEI Numbers
518
Registration Numbers
518
Same Product Code
795
Applicant Total
5
Review Days
105
Basic Information
- Device Name
- Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C
- K Number
- K203332
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.2910
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- HeTaiDa Technology Co., Ltd.
- Date Received
- November 12, 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 HeTaiDa Technology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K223170 | Electronic Blood Pressure Monitor, model: HTD6602US | Dec 5, 2023 | Substantially Equivalent |
| K200159 | Non-contact Infrared Body Thermometer, model:HTD8823US | Jan 5, 2021 | Substantially Equivalent |
| K180387 | Infrared Ear Thermometer | Jan 10, 2019 | Substantially Equivalent |
| K180385 | Infrared Body Thermometer | May 11, 2018 | Substantially Equivalent |