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This document provides details regarding the submission of a medical device (CMAP Pro), including its manufacturer information, device classification, intended use, device description, comparison
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How to fill out 510k summary for k113074
How to fill out 510(k) Summary for K113074
01
Start by gathering all necessary product information, including device name, classification, and intended use.
02
Prepare the 510(k) submission package, ensuring it meets FDA requirements.
03
Provide a detailed description of the device, including design, materials, and specifications.
04
Include data supporting substantial equivalence to a predicate device, including performance testing results.
05
Document any labeling information, including instructions for use and promotional materials.
06
Review the summary for accuracy, completeness, and compliance with FDA guidelines.
07
Submit the 510(k) Summary electronically through the FDA’s submission portal.
Who needs 510(k) Summary for K113074?
01
Manufacturers of medical devices that intend to market a product that requires FDA clearance.
02
Companies seeking to demonstrate that their device is substantially equivalent to an existing legally marketed device (predicate).
03
Organizations needing to comply with FDA regulations to ensure market access for their medical device.
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How to look up 510k?
Users can search the FDA 510(k) database by entering the name of a specific medical device, the name of the applicant who filed the 510(k) premarket notification paperwork for the device, or by entering the specific 510(k) number or product code associated with a given device.
How to look up a 510k?
The 510(k) clearance process involves a comprehensive review of safety and performance data for the device, which may include scientific, non-clinical, and clinical data, as appropriate, to determine if a new device is substantially equivalent to a device that is already on the market (that is, a predicate device).
Are 510 K submissions public?
Go to the Devices@FDA Database. In the Enter a search term in the space below field, type the name of the device or the company name. You can type the exact name of a specific device or a generic name for a category of devices (such as pacemaker). Click Search.
What is the 510k summary?
Users can search the FDA 510(k) database by entering the name of a specific medical device, the name of the applicant who filed the 510(k) premarket notification paperwork for the device, or by entering the specific 510(k) number or product code associated with a given device.
What is the FDA granted 510 K clearance?
The 510(k) regulatory pathway is a submission process that medical device manufacturers use to get clearance from the FDA to market an eligible product in the U.S. Under the 510(k) pathway, a medical device manufacturer submits a premarket notification to the FDA, which includes information about the device's intended
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What is 510(k) Summary for K113074?
The 510(k) Summary for K113074 is a premarket submission made to the FDA that demonstrates that a medical device is substantially equivalent to an existing device that is already legally marketed.
Who is required to file 510(k) Summary for K113074?
Manufacturers of medical devices that wish to market a device in the United States, which are deemed to require a 510(k) submission, are required to file the 510(k) Summary for K113074.
How to fill out 510(k) Summary for K113074?
To fill out the 510(k) Summary for K113074, manufacturers must provide information including the device's name, intended use, description, labeling, and detailed information about the substantial equivalence to a predicate device.
What is the purpose of 510(k) Summary for K113074?
The purpose of the 510(k) Summary for K113074 is to inform the FDA of the device's safety and effectiveness and to establish that it is substantially equivalent to a legally marketed device.
What information must be reported on 510(k) Summary for K113074?
The 510(k) Summary for K113074 must report information such as the device's name, proposed indications for use, technology comparison with a predicate device, a description of the device, labeling information, and data supporting substantial equivalence.
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