FDA 510 (k) Premarket Notification

An FDA 510 (k) is the technical documentation required to market a medical device in the USA. The FDA 510 (k) is predominantly for Class II medical devices. Amongst other things, the document must show the test methods and results. The team at Cranage Veritas can assist with classifying medical devices, identifying the test procedures and technical documentation. Get in touch with our team to see how we can help you achieve FDA compliance

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