FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
RII INFRARED EAR THERMOMETER, MODELS TH5XY SERIES
K Number: K063185
·
Decision Nov 17, 2006
Classifications
1
FEI Numbers
488
Registration Numbers
488
Same Product Code
797
Applicant Total
15
Review Days
28
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Basic Information
- Device Name
- RII INFRARED EAR THERMOMETER, MODELS TH5XY SERIES
- K Number
- K063185
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.2910
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radiant Innovation, Inc.
- Date Received
- October 20, 2006
- Decision Date
- November 17, 2006
- 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 Radiant Innovation, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K240648 | Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) | Jun 5, 2024 | Substantially Equivalent |
| K163601 | RII Smart IR Thermometer | Dec 6, 2018 | Substantially Equivalent |
| K162083 | RII Multi-function Infrared Thermometer, Model TH52Z | Jan 9, 2017 | Substantially Equivalent |
| K121428 | NON-CONTACT CLINICAL THERMOMETER | Jul 17, 2012 | Substantially Equivalent |
| K111637 | INFRARED EAR THERMOMETER | Dec 6, 2011 | Substantially Equivalent |
| K103097 | INFRARED EAR THERMOMETER | Dec 29, 2010 | Substantially Equivalent |
| K102187 | RII INFRARED EAR THERMOMETER, | Dec 10, 2010 | Substantially Equivalent |
| K101253 | RII INFRARED EAR THERMOMETER, MODEL: TH60N | Jun 29, 2010 | Substantially Equivalent |
| K070976 | RII INFRARED EAR THERMOMETER, MODEL TH01BN | Apr 20, 2007 | Substantially Equivalent |
| K051269 | RII INFRARED EAR THERMOMETER, MODELS TH00XY SERIES | Sep 9, 2005 | Substantially Equivalent |