Medical Device 510 (k) Submission
we have a medical device, and we are working on our 510k submission. For the fda we need some performance testing/verification testing.
Please let me know if you have experience in working with x ray dental sensors and we would love to work with you.
Thanks,+14 Other Responses
i represent *************medical engineering pvt. Ltd., mumbai india.George philips was established in 1995 and today, is one of india's leading manufacturer and supplier of 'life saving medical devices and disposables' to the healthcare industry, both domestically and internationally.
I am writing to express my interest in seeking your assistance for the submission of 2 of our products (iv flow regulator and disposable pressure transducer kit) for 510 k approval.Kindly provide a quote for processing our application.
Awaiting your reply at the earliest.+12 Other Responses
Fda 510(k) Guidance
I would like to get a better understandign of the fda 510(k) process. What is all required in the context of my device.
My device is a camera that captures 3d data to allow for highly accurate 3d surface measurements. It will enable better tracking of the healing progress for multiple applications one in particular is chronic wounds.
Thank you.+3 Other Responses