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.
Types of Clinical 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.
Useful Information
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