A Clinical Thermometer is a device used to measure the body temperature of a patient so it is considered as a medical Device as per European and US FDA Medical Device Regulation.
Generally, Thermometers are used in clinics by doctors, so they are also called a doctor’s thermometers or medical thermometers.
The temperature in a thermometer is recorded in both Celsius scale and Fahrenheit temperature scales and run from 35 degree Celsius to 42 degree Celsius.
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The different types of Thermometers as and the device code and regulation number:
# |
Device Type |
Device code |
Regulation Number |
Device Class
|
Identification |
1 | Clinical Electronic Thermometer | PXH | 880.2910 |
(ED) |
A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.
|
2 | Clinical Infrared Thermometer | FLL | 880.2910 |
Class 2 |
|
3 | Clinical Electronic Thermometer | OZK | 880.2910 |
Class 2 510k |
|
4 |
Fever Monitoring Kit |
PWW | 880.2910 |
Class 2 510k |
|
5 | Clinical color change Thermometer |
FQZ
|
880.2900 |
Class 1 510k exempt |
A liquid crystal forehead temperature strip is a device applied to the forehead that is used to indicate the presence or absence of fever or to monitor body temperature changes. The device displays the color changes of heat-sensitive liquid crystals corresponding to the variation in the surface temperature of the skin. The liquid crystals, which are cholesteric esters, are sealed in plastic.
|
5 | Clinical Mercury Thermometer | FLK | 880.2920 |
Class 2 510k |
A clinical mercury thermometer is a device used to measure oral, rectal, or axillary (armpit) body temperature using the thermal expansion of mercury.
|
6 | Liquid crystal forehead temperature strip | KPD | 880.2200 |
Class 2 510k |
A liquid crystal forehead temperature strip is a device applied to the forehead that is used to indicate the presence or absence of fever or to monitor body temperature changes. The device displays the color changes of heat-sensitive liquid crystals corresponding to the variation in the surface temperature of the skin. The liquid crystals, which are cholesteric esters, are sealed in plastic
|
Know more about CE Marking of Clinical Thermometers.