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This document outlines the 510(k) submission for the ROTEM® delta system, its intended use, performance data, and regulatory filing details.
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How to fill out rotem delta thromboelastometry system
How to fill out ROTEM® delta Thromboelastometry System 510(k) Submission
01
Gather all required documentation including device description, intended use, and labeling.
02
Prepare a list of all technological characteristics of the ROTEM® delta Thromboelastometry System.
03
Conduct a thorough review of predicate devices and ensure you have their 510(k) numbers.
04
Compile testing data, including bench tests, biocompatibility, and any clinical data if applicable.
05
Complete the 510(k) application form, ensuring all sections are filled out accurately.
06
Organize your submission, ensuring all documents are clearly labeled and in the correct order.
07
Submit the application electronically or by mail, following the FDA’s submission guidelines.
08
Pay the required user fee for the 510(k) submission.
09
Monitor the application status through the FDA’s database until you receive feedback or approval.
Who needs ROTEM® delta Thromboelastometry System 510(k) Submission?
01
Healthcare institutions looking to use ROTEM® delta for thromboelastometry.
02
Manufacturers who need to market the ROTEM® delta device in the U.S.
03
Regulatory professionals managing medical device compliance.
04
Clinical researchers requiring data on the system for studies.
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What is ROTEM® delta Thromboelastometry System 510(k) Submission?
The ROTEM® delta Thromboelastometry System 510(k) Submission is a premarket notification to the FDA that demonstrates the safety and effectiveness of this thromboelastometry device, which is used for monitoring and managing hemostasis in patients.
Who is required to file ROTEM® delta Thromboelastometry System 510(k) Submission?
Manufacturers of the ROTEM® delta Thromboelastometry System or any entity seeking to market the device in the United States are required to file a 510(k) Submission.
How to fill out ROTEM® delta Thromboelastometry System 510(k) Submission?
To fill out the 510(k) Submission, manufacturers must provide detailed information about the device, including its intended use, design, materials, labeling, and performance data, as well as evidence of substantial equivalence to a legally marketed device.
What is the purpose of ROTEM® delta Thromboelastometry System 510(k) Submission?
The purpose of the ROTEM® delta Thromboelastometry System 510(k) Submission is to obtain FDA clearance to market the device by proving its safety, efficacy, and that it is substantially equivalent to existing devices.
What information must be reported on ROTEM® delta Thromboelastometry System 510(k) Submission?
The submission must report information including device description, indications for use, technological characteristics, performance testing results, labeling, and a comparative analysis with predicate devices.
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