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This document outlines the 510(k) premarket notification for the EG-3630UR Ultrasound Video Gastroscope, detailing device specifications, intended use, and equivalence to previously approved devices.
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How to fill out 510ksummary eg-3630ur ultrasound video
How to fill out 510(k)Summary EG-3630UR, Ultrasound Video Gastroscope
01
Gather all necessary device information including the device name, model number, and intended use.
02
Prepare a detailed description of the device, including its physical characteristics and technical specifications.
03
Document the intended use and indications for the device, ensuring they align with FDA classifications.
04
Provide performance data, including clinical testing results if applicable, to demonstrate safety and effectiveness.
05
Include labeling and packaging details to show compliance with FDA requirements.
06
Outline comparisons with predicate devices to demonstrate substantial equivalence.
07
Submit your 510(k) summary through the FDA's online portal, ensuring all sections are completed accurately.
08
Keep a copy of your submission and obtain confirmation of receipt from the FDA.
Who needs 510(k)Summary EG-3630UR, Ultrasound Video Gastroscope?
01
Manufacturers of the Ultrasound Video Gastroscope who wish to market their device in the U.S.
02
Healthcare providers or institutions that plan to use the Ultrasound Video Gastroscope for patient diagnostics.
03
Regulatory affairs professionals involved in the submission of medical device applications.
04
Investors or stakeholders in companies developing devices similar to the Ultrasound Video Gastroscope who need to understand regulatory pathways.
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What is 510(k) Summary EG-3630UR, Ultrasound Video Gastroscope?
The 510(k) Summary EG-3630UR refers to a premarket submission made to the FDA for a specific type of medical device, which in this case is an ultrasound video gastroscope. This device is designed for endoscopic procedures that require visualization and ultrasound capabilities within the gastrointestinal tract.
Who is required to file 510(k) Summary EG-3630UR, Ultrasound Video Gastroscope?
Manufacturers of the ultrasound video gastroscope or their authorized representatives are required to file the 510(k) Summary. This applies to any entity that intends to market or distribute the device in the United States.
How to fill out 510(k) Summary EG-3630UR, Ultrasound Video Gastroscope?
To fill out the 510(k) Summary, the filer must provide detailed information about the device, including its intended use, design, materials, labeling, performance testing, and comparisons to predicate devices. Specific forms and guidance can be found on the FDA's website.
What is the purpose of 510(k) Summary EG-3630UR, Ultrasound Video Gastroscope?
The purpose of the 510(k) Summary is to demonstrate to the FDA that the ultrasound video gastroscope is safe and effective for its intended use and is substantially equivalent to a legally marketed predicate device.
What information must be reported on 510(k) Summary EG-3630UR, Ultrasound Video Gastroscope?
The information that must be reported includes device name, classification, intended use, description of the device, labeling, risk analysis, performance testing results, sterility information, and any adverse events related to the device.
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