FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
TAIDOC TD-11 SERIES AND CLEVER TD-1112 EAR/SKIN/ SURFACE IR THERMOMETERS & FORA IR16/17 EAR THERMOMETER
K Number: K083299
·
Decision Dec 10, 2008
Classifications
1
FEI Numbers
518
Registration Numbers
518
Same Product Code
795
Applicant Total
118
Review Days
30
Basic Information
- Device Name
- TAIDOC TD-11 SERIES AND CLEVER TD-1112 EAR/SKIN/ SURFACE IR THERMOMETERS & FORA IR16/17 EAR THERMOMETER
- K Number
- K083299
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.2910
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- TaiDoc Technology Corporation
- Date Received
- November 10, 2008
- Decision Date
- December 10, 2008
- 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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