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K13 2240-Page 1 of 4 EC D 162013 Section IV: 510k Summary Applicant's Identification Applicant Grand way Technology (Shenzhen) Limited Address Block 6 & 7, Zhu King Industrial Zone, Ping Shan, Long
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How to fill out section iv 510k summary
How to fill out section iv 510k summary:
01
Start by gathering all the necessary information and documents related to your medical device. This may include data regarding the device design, clinical testing, and intended use.
02
Begin section iv by providing a clear and concise summary of your device and its intended use. Detail the specific indications for use, patient population, and any other relevant information.
03
Next, include a comprehensive description of the device's technological characteristics, highlighting its design, materials used, and any unique features or functionality.
04
Provide a detailed summary of the device's performance characteristics, such as its safety and effectiveness profiles. Include information on any clinical studies or trials conducted to support these claims.
05
Document all labeling, including the device's intended use, warnings, precautions, and instructions for use. Additionally, include any relevant advertising or promotional materials.
06
If applicable, mention any accessories or components that are integral to the device's functioning and their intended use.
07
Discuss the device's failure modes and potential risks associated with its use. Provide a thorough analysis of identified hazards and explain how they are mitigated through design controls or other measures.
08
Include a summary of any clinical data obtained from your device or similar devices in the market. This should demonstrate the device's safety and effectiveness in treating the intended patient population.
09
Conclude the section by referencing any relevant standards or guidelines to which your device conforms.
10
Review and proofread your section iv summary to ensure accuracy, clarity, and completeness. Make any necessary revisions before submitting it as part of your 510k submission.
Who needs section iv 510k summary?
01
Medical device manufacturers who intend to market a new device or make changes to an existing device and require clearance from the U.S. Food and Drug Administration (FDA).
02
Regulatory affairs professionals responsible for preparing and submitting the 510k application.
03
Healthcare professionals involved in the clinical testing, evaluation, or use of medical devices.
04
FDA reviewers who assess the safety and effectiveness of medical devices based on the information presented in the 510k submission.
05
Other stakeholders, such as investors or potential partners, who require a comprehensive understanding of the device and its regulatory status.
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What is section iv 510k summary?
Section IV 510(k) summary is a summary of the safety and effectiveness data provided in a 510(k) submission.
Who is required to file section iv 510k summary?
Medical device manufacturers are required to file section IV 510(k) summary.
How to fill out section iv 510k summary?
To fill out Section IV 510(k) summary, include a summary of safety and effectiveness data provided in the 510(k) submission.
What is the purpose of section iv 510k summary?
The purpose of Section IV 510(k) summary is to provide a concise overview of the safety and effectiveness data for the device.
What information must be reported on section iv 510k summary?
The information reported on Section IV 510(k) summary must include a summary of safety and effectiveness data for the device.
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