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KineGraph VMA TM Sy tem v2. 2 subject. K130743 the cleared device Classification Name Radiological Product Code LLZ ALIStin. IexaS 78746 l ax 512 334-5500 KineGraph VM System v2. 2 Regulation Number 21 CFR 892. 2050 Regulatory Class 11 Dated December 20 2013 Received December 20 2013 Dear Dr. Image processing operators who are Ortho Kinematics Inc. employees operate the KINEGRAPH VMA TM software to process images and facilitate template placement for the prescriber. 2 SUBMITTED BY John Smith...
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What is k133875 - fda?
k133875 - fda is a form submitted to the FDA for approval of a new medical device.
Who is required to file k133875 - fda?
The manufacturer or sponsor of the medical device is required to file k133875 - fda.
How to fill out k133875 - fda?
k133875 - fda can be filled out online through the FDA's electronic submission system.
What is the purpose of k133875 - fda?
The purpose of k133875 - fda is to seek approval for the marketing of a new medical device.
What information must be reported on k133875 - fda?
k133875 - fda requires information on the device description, proposed indications for use, and supporting data.
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