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JUL 2 2 2011 510(k) Summary Page I of 4 Company Advanced Brain Monitoring, Inc. 2237 Faraday Avenue, Suite 100 Carlsbad, CA 92008 Tel (760) 720-0099 Fa — (760) 476-3620 Official Contact: Daniel
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What is jul 2 2 510k?
A jul 2 2 510k is a submission made to the U.S. Food and Drug Administration (FDA) for a premarket notification of a medical device.
Who is required to file jul 2 2 510k?
Any person or organization that wants to market a medical device in the United States is required to file a jul 2 2 510k.
How to fill out jul 2 2 510k?
To fill out a jul 2 2 510k, you need to provide information about the medical device, its intended use, performance data, and comparisons to similar marketed devices. The FDA provides specific guidance on how to complete the submission.
What is the purpose of jul 2 2 510k?
The purpose of jul 2 2 510k is to demonstrate that the new medical device is substantially equivalent to an existing device already legally marketed in the United States, or that it does not pose any significant risk to public health.
What information must be reported on jul 2 2 510k?
A jul 2 2 510k submission must include information such as device description, intended use, performance data, comparison to similar devices, proposed labeling, and any clinical studies or data supporting the safety and effectiveness of the device.
When is the deadline to file jul 2 2 510k in 2023?
The deadline to file a jul 2 2 510k in 2023 depends on the specific device and its classification. It is recommended to consult the FDA's official website or contact the FDA directly for the most accurate and up-to-date information regarding deadlines.
What is the penalty for the late filing of jul 2 2 510k?
The FDA may take regulatory actions against a manufacturer for the late filing of a jul 2 2 510k. The specific penalties can vary based on the circumstances, but may include fines, product seizure, or refusal to allow the device to be marketed in the United States.
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