FDA 510k for Clinical Thermometers

FDA 510k for Clinical Thermometers 1

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.

The different types of Thermometers as and the device code and regulation number:

#

Device TypeDevice

code

Regulation Number 

Device Class

 

 

Identification

1Clinical Electronic ThermometerPXH880.2910

Class 2

  (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.

 

 

2Clinical Infrared ThermometerFLL880.2910

Class 2

510k

3Clinical Electronic ThermometerOZK880.2910

Class 2

510k

4Fever Monitoring

Kit

PWW880.2910

Class 2

510k

5Clinical 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.

 

 

5Clinical Mercury ThermometerFLK880.2920

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.

 

 

6Liquid crystal forehead temperature stripKPD880.2200

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

 

 

To know more about CE Marking of Clinical Thermometers