Get the free 510(k) Summary for FORA ComfortScan Ear Thermometer - accessdata fda
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This document provides a summary of safety and effectiveness information for the FORA ComfortScan Ear Thermometer submitted in accordance with the 510(k) regulations of the FDA.
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How to fill out 510(k) Summary for FORA ComfortScan Ear Thermometer
01
Gather product information including the name, model number, and intended use.
02
Identify the predicate device to which the FORA ComfortScan Ear Thermometer is being compared.
03
Provide a detailed description of the device including its design, materials, and features.
04
Outline the device’s intended use and indications for use.
05
Include performance testing results, including clinical and non-clinical studies.
06
Demonstrate compliance with applicable FDA regulations and standards.
07
Detail potential risks associated with use and how they are mitigated.
08
Include labeling and instructions for use that will accompany the device.
09
Prepare a comprehensive summary that highlights all relevant information in a clear and concise manner.
Who needs 510(k) Summary for FORA ComfortScan Ear Thermometer?
01
Manufacturers seeking FDA clearance to market the FORA ComfortScan Ear Thermometer.
02
Quality assurance and regulatory affairs teams within the manufacturing company.
03
Healthcare providers or institutions interested in utilizing the thermometer in clinical settings.
04
Distributors and retailers planning to sell the product.
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People Also Ask about
How do you use an accurate digital ear thermometer?
0:00 1:00 And take the highest reading as the baby's temperature. Always refer to the manufacturer'sMoreAnd take the highest reading as the baby's temperature. Always refer to the manufacturer's instruction for the reference normal temperature. Range as it varies with different brands and models.
Do you add a degree when taking temperature in the ear?
You can always remeasure both ears and see if you get different results the second time round. If there is a genuine temperature difference between the ears it can mean there is an ear or throat infection on one side.
What is the explanation of ear thermometer?
Remote ear thermometers, also called tympanic thermometers, use an infrared ray to measure the temperature inside the ear canal. The pros: When positioned properly, infrared ear thermometers are quick and generally comfortable for children and adults.
How does an ear thermometer work?
Tympanic thermometers use an infrared sensor to measure the temperature inside the ear canal and can give results within seconds. Ear thermometers are noninvasive, hygienic, quick, and easy to use. Children may also find them more comfortable.
What is a normal ear thermometer reading?
Oral: 98.6F (37C) : 99.6F (37.5C) Ear: 99.6F (37.5C)
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What is 510(k) Summary for FORA ComfortScan Ear Thermometer?
The 510(k) Summary for FORA ComfortScan Ear Thermometer is a premarket submission made to the FDA that demonstrates the device is safe and effective, and is substantially equivalent to a legally marketed device.
Who is required to file 510(k) Summary for FORA ComfortScan Ear Thermometer?
Manufacturers or importers of the FORA ComfortScan Ear Thermometer who wish to market the device in the United States are required to file the 510(k) Summary.
How to fill out 510(k) Summary for FORA ComfortScan Ear Thermometer?
To fill out the 510(k) Summary for FORA ComfortScan Ear Thermometer, manufacturers need to provide information including device description, intended use, technological characteristics, comparison to predicate devices, and performance data.
What is the purpose of 510(k) Summary for FORA ComfortScan Ear Thermometer?
The purpose of the 510(k) Summary for FORA ComfortScan Ear Thermometer is to inform the FDA about the device's performance, intended use, and compliance with safety and effectiveness standards, thereby enabling regulatory review.
What information must be reported on 510(k) Summary for FORA ComfortScan Ear Thermometer?
The information that must be reported includes the device's name, manufacturer details, a summary of the safety and effectiveness data, indications for use, and a comparison with a predicate device.
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