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J2It JAN 10 2013 510(k) SUMMARY EVIL EXTRA III VIDEO SYSTEM ENDOSCOPIC VIDEO IMAGING SYSTEM January 8,12013 1 General Information * Applicant: OLYMPUS MEDICAL SYSTEMS CORP. Official Correspondent:
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What is j2it jan 10 510k?
j2it jan 10 510k is a submission made to the Food and Drug Administration (FDA) to demonstrate that a medical device is safe and effective for use.
Who is required to file j2it jan 10 510k?
Manufacturers of medical devices are required to file j2it jan 10 510k with the FDA before marketing their product.
How to fill out j2it jan 10 510k?
To fill out j2it jan 10 510k, manufacturers must provide information about the device, its intended use, and any scientific data supporting its safety and effectiveness.
What is the purpose of j2it jan 10 510k?
The purpose of j2it jan 10 510k is to demonstrate to the FDA that a medical device is at least as safe and effective as a legally marketed device.
What information must be reported on j2it jan 10 510k?
Information that must be reported on j2it jan 10 510k includes device description, intended use, technological characteristics, performance testing data, and labeling.
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