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510(k)Summarytif11o7T×5
OT2 5 21Submitter Information:
Submitter:Chart Equal Technologies Inc.
12230 World Trade Drive, Suite 100
San Diego, CA 92128Contact:
Phone:
FAX:Brian Jarrell, Manager of
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This form summarizes the key aspects of the 510(k) submission and provides a concise overview of the medical device being reviewed.
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What is 510ksummary tif 11o7t5?
The 510ksummary tif 11o7t5 is a summary of a premarket notification submission for medical devices.
Who is required to file 510ksummary tif 11o7t5?
Manufacturers of medical devices are required to file the 510ksummary tif 11o7t5.
How to fill out 510ksummary tif 11o7t5?
The 510ksummary tif 11o7t5 should be filled out with detailed information about the medical device, its intended use, and any supporting data.
What is the purpose of 510ksummary tif 11o7t5?
The purpose of the 510ksummary tif 11o7t5 is to demonstrate that the medical device is substantially equivalent to a legally marketed device.
What information must be reported on 510ksummary tif 11o7t5?
The 510ksummary tif 11o7t5 must include information about the device description, performance data, and intended use.
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