How to check the FDA certificate of a non-contact thermometer?

What’s Infrared non-contact thermometer?

What’s the Con and Pro of the non-contact thermometer?

1.What’s Infrared non-contact thermometer?

Measuring a person’s temperature can be done in several ways. One method to measure a person’s surface temperature is with the use of non-contact infrared thermometers (NCITs). NCITs may be used to reduce cross-contamination risk and minimize the risk of spreading disease.

https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/non-contact-infrared-thermometers

While typically 98.6°F (37.0°C) is considered a “normal” temperature, some studies have shown that “normal” body temperature can be within a wide range, from 97°F (36.1°C) to 99°F (37.2°C). Before NCITs are used, it is important to understand the benefits, limitations, and proper use of these thermometers. Improper use of NCITs may lead to inaccurate measurements of temperature.

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2. What’s the Con and Pro of the non-contact thermometer?

Benefits

Non-contact approach may reduce the risk of spreading disease between people being evaluated
Easy to use
Easy to clean and disinfect
Measures temperature and displays a reading rapidly
Provides ability to retake a temperature quickly

Limitations

How and where the NCIT is used may affect the measurement (for example, head covers, environment, positioning on forehead).

The close distance required to properly take a person’s temperature represents a risk of spreading disease between the person using the device and the person being evaluated.

3. How to check the FDA certificate of a non-contact thermometer?

How to check the FDA certificate of a non-contact thermometer?
There are two database you can use for FDA information search, Establishment Registration & Device Listing and the 510(k) Premarket Notification.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

For Establishment Registration information, you can input the official English name of the company into the Establishment / Trade Name or Owner/Operator Name. Only one blank been filled would be enough.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

After a company register in the FDA database, they need have

How to check the FDA certificate of a non-contact thermometer? | BH CARE