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Summary of safety and effectiveness information for the REEVUE Indirect Calorimeter as part of a premarket notification submitted to the FDA.
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How to fill out 510(k) Summary for the REEVUE Indirect Calorimeter
01
Identify the device: Clearly state the name and intended use of the REEVUE Indirect Calorimeter.
02
Provide device description: Detail the design, components, and functionality of the device.
03
List predicate devices: Identify and describe similar devices that have previously received 510(k) clearance.
04
Discuss technological characteristics: Compare the technological features of the REEVUE with those of predicate devices.
05
Address performance data: Include any clinical data or laboratory tests that support the safety and effectiveness of the device.
06
Include labeling information: Provide draft labels and instructions for use.
07
Submit summary: Ensure all required information is clear and well-organized before submission to the FDA.
Who needs 510(k) Summary for the REEVUE Indirect Calorimeter?
01
Manufacturers of the REEVUE Indirect Calorimeter need to submit a 510(k) Summary to the FDA to demonstrate that the device is safe and effective for its intended use.
02
Healthcare providers and users of the device may also be interested in the 510(k) Summary to understand its regulatory status and efficacy.
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People Also Ask about
What is the principle of indirect calorimeter?
Indirect calorimetry is based on the premise that gas volumes and concentrations exchanged at the mouth reflect cellular metabolic activity. By measuring the difference between inspired and expired levels of oxygen and carbon dioxide, determinants of VO2 and VCO2 can be obtained (Table 3).
What is the metabolic test via indirect calorimetry?
This indirect calorimetry machine evaluates carbon dioxide production and oxygen use to calculate how much heat your body produces. This test provides unique information, is noninvasive and may be combined with other methods to determine energy output.
What is indirect calorimetry using a metabolic cart?
An indirect calorimetry test is performed using a metabolic cart that includes a computer, blood pressure cuff and breathing mask. The setup of the test depends on the purpose of having the test done.
What is the CPT code for indirect calorimetry?
Indirect calorimetry is CPT code #94690 and is covered by Medicare and most insurance providers.
What is the most accurate way to measure RMR?
Jeor equation is considered a more accurate and reliable RMR calculation method than the Harris Benedict equation takes diverse body compositions and ethnicities into consideration. Although the Mifflin-St. Jeor equation is more accurate, like any equation, it is still just an estimate with a marginal risk of error.
What is the interpretation of indirect calorimetry?
Indirect calorimetry is a technique that measures oxygen consumption and carbon dioxide production to calculate resting energy expenditure and respiratory quotient (RQ) and to measure the actual energy expenditure (measured energy expenditure [MEE]) of a patient.
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What is 510(k) Summary for the REEVUE Indirect Calorimeter?
The 510(k) Summary for the REEVUE Indirect Calorimeter is a document submitted to the FDA that provides information demonstrating that the device is safe and effective for its intended use, comparing it to a legally marketed predicate device.
Who is required to file 510(k) Summary for the REEVUE Indirect Calorimeter?
Manufacturers and distributors of the REEVUE Indirect Calorimeter who intend to market the device in the United States are required to file the 510(k) Summary.
How to fill out 510(k) Summary for the REEVUE Indirect Calorimeter?
To fill out the 510(k) Summary for the REEVUE Indirect Calorimeter, manufacturers must provide detailed information including device description, intended use, technological characteristics, performance data, and any labeling information.
What is the purpose of 510(k) Summary for the REEVUE Indirect Calorimeter?
The purpose of the 510(k) Summary for the REEVUE Indirect Calorimeter is to demonstrate to the FDA that the device is substantially equivalent to an existing legally marketed device and meets safety and effectiveness requirements.
What information must be reported on 510(k) Summary for the REEVUE Indirect Calorimeter?
The 510(k) Summary for the REEVUE Indirect Calorimeter must report information such as the manufacturer's details, device description, intended use, performance testing results, labeling details, and comparison with predicate devices.
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