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SUMMARY OF SAFETY AND EFFECTIVENESS JAN 6 62012 Assigned 510(k) Number The assigned 510(k) number is: k112523. Sponsor Name and Address Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarry
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How to fill out assigned 510k number
How to fill out assigned 510k number?
01
Gather all necessary documentation and information related to the medical device for which the 510k number is being assigned.
02
Ensure that the necessary forms, such as FDA Form 3514, are properly filled out with accurate and complete information.
03
Submit the completed forms and documentation electronically through the FDA's electronic submissions gateway (ESG).
04
Pay the required fees associated with the submission, if applicable.
05
Await confirmation and notification from the FDA regarding the assigned 510k number.
Who needs assigned 510k number?
01
Manufacturers of medical devices that are subject to premarket notification requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
02
Importers of medical devices who are bringing devices into the United States for the first time.
03
Distributors and other entities involved in the commercialization and sale of medical devices in the United States.
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What is assigned 510k number?
The assigned 510k number is a unique identification number given to medical devices that have been cleared by the FDA.
Who is required to file assigned 510k number?
Manufacturers of medical devices are required to file the assigned 510k number for their products with the FDA.
How to fill out assigned 510k number?
The assigned 510k number is filled out by submitting a premarket notification (510k) to the FDA, which includes all relevant information about the medical device.
What is the purpose of assigned 510k number?
The purpose of the assigned 510k number is to provide a unique identifier for medical devices that have been cleared by the FDA, ensuring their traceability and regulatory compliance.
What information must be reported on assigned 510k number?
The assigned 510k number requires reporting of detailed information about the medical device, including its intended use, design specifications, performance data, and any potential risks or side effects.
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