FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INFRARED EAR THERMOMETER, MODELS TH88 SERIES
K Number: K020504
·
Decision Feb 28, 2002
Classifications
1
FEI Numbers
518
Registration Numbers
518
Same Product Code
795
Applicant Total
8
Review Days
13
Basic Information
- Device Name
- INFRARED EAR THERMOMETER, MODELS TH88 SERIES
- K Number
- K020504
- 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
- February 15, 2002
- Decision Date
- February 28, 2002
- 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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| K Number | Device Name | ||
|---|---|---|---|
| K111637 | INFRARED EAR THERMOMETER | Dec 6, 2011 | Substantially Equivalent |
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| K102187 | RII INFRARED EAR THERMOMETER, | Dec 10, 2010 | Substantially Equivalent |
| K063185 | RII INFRARED EAR THERMOMETER, MODELS TH5XY SERIES | Nov 17, 2006 | Substantially Equivalent |
| K040377 | RII INFRARED EAR THERMOMETER, MODELS THXXN SERIES | Sep 16, 2004 | Substantially Equivalent |
| K030324 | RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SERIES | Feb 27, 2003 | Substantially Equivalent |
| K011059 | INFARED EAR THERMOMETER, MODEL TH8 SERIES | Sep 17, 2001 | Substantially Equivalent |