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This document provides a summary and details regarding the 510(k) premarket notification for The Infrared Forehead Thermometer, including its intended use, device description, technological characteristics,

How to fill out 510k summary for form

How to fill out 510(k) Summary for The Infrared Forehead Thermometer, FS-300&301

1. Begin with a clear title that identifies the device, including its name and model numbers (FS-300 & FS-301).
2. Provide a description of the device that includes its intended use and indications for use.
3. Include a detailed description of the technology and principles of operation of the Infrared Forehead Thermometer.
4. List the components and materials used in the device along with their specifications.
5. Describe the performance testing results, including biocompatibility, accuracy, and precision data.
6. Provide a summary of any clinical testing, if applicable, including the study design and outcomes.
7. Compare the device to a predicate device, highlighting similarities and differences.
8. Include labeling and instructions for use, including any warnings, cautions, and contraindications.
9. Detail any potential risks associated with the device and how they are mitigated.
10. Conclude with a statement of compliance with applicable FDA requirements.

Who needs 510(k) Summary for The Infrared Forehead Thermometer, FS-300&301?

1. Manufacturers of the Infrared Forehead Thermometer (FS-300 & FS-301) who wish to market the device in the United States.
2. Regulatory affairs professionals involved in the submission process for medical devices.
3. Importers and distributors of the device who need to ensure compliance with FDA regulations.

People Also Ask about

What is the use of infrared forehead thermometer?

In an effort to contain any possible risk of infection, infrared thermometers are a good way to detect the body temperature. It measures the temperature through the forehead from a distance in seconds. While using the Infrared thermometer you don't need to have physical contact with the person you are testing.

How to correctly use an infrared thermometer?

0:08 1:15 Button. We can have body if you're checking body temperature. The room if you're checking a roomMoreButton. We can have body if you're checking body temperature. The room if you're checking a room temperature. And a surface um if you're checking the temperature of a surface.

What is a normal forehead temperature infrared?

With the most accurate HIT in our possession, the current study came up with a normal range of FT (31.0°C to 35.6°C or 97.8°F to 96.1°F). We suggest further studies with a larger population with different brands of handheld thermometers to confirm that forehead temperatures >35.6°C (>96.1°F) are indicative of fever.

What is a healthy forehead temperature range?

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.

What is normal range for infrared thermometer forehead?

It would be normal to read an actual forehead skin surface temperature between 91F and 94F if using a general-purpose infrared thermometer. Some infrared thermometers have an “adjustable emissivity feature”.

What is the effective range of an infrared thermometer?

A range of -58°F to 1022°F (-50°C to 550°C) would cover a broad spectrum of temperatures encountered in everyday tasks, making it suitable for home use, DIY projects, and light industrial applications.

For pdfFiller’s FAQs

What is 510(k) Summary for The Infrared Forehead Thermometer, FS-300&301?

The 510(k) Summary for The Infrared Forehead Thermometer, FS-300&301 is a document submitted to the FDA that provides details on the design, intended use, and performance of the thermometer, demonstrating that it is safe and effective for its intended use and substantially equivalent to a legally marketed device.

Who is required to file 510(k) Summary for The Infrared Forehead Thermometer, FS-300&301?

Manufacturers or importers of The Infrared Forehead Thermometer, FS-300&301 are required to file a 510(k) Summary if they intend to market the device in the United States.

How to fill out 510(k) Summary for The Infrared Forehead Thermometer, FS-300&301?

To fill out the 510(k) Summary for The Infrared Forehead Thermometer, FS-300&301, manufacturers must provide information including device description, intended use, manufacturer details, labeling, and performance testing results. They must also compare the new device to a similar existing device to demonstrate substantial equivalence.

What is the purpose of 510(k) Summary for The Infrared Forehead Thermometer, FS-300&301?

The purpose of the 510(k) Summary for The Infrared Forehead Thermometer, FS-300&301 is to inform the FDA and the public about the device's safety and effectiveness, allowing for regulatory approval for market entry.

What information must be reported on 510(k) Summary for The Infrared Forehead Thermometer, FS-300&301?

The information reported on the 510(k) Summary for The Infrared Forehead Thermometer, FS-300&301 includes the device's name, intended use, classification, labeling, a comparison to predicate devices, and data from performance testing, such as accuracy and reliability assessments.