United States: FDA Premarket Notifications 510(K)

• Creation and submission of 510(k). We will follow through until clearance
• Research predicate devices
• Research applicable guidance documents
• Research applicable consensus standards
• Determine type of submission - traditional, abbreviated or special
• Help with device descriptions, intended use, labeling, instructions for use
• Guidance on electrical safety and Electro-Magnetic Compatibility (EMC) testing
• Provide guidance on applicable standards (as well as consensus standards if they exist)
• Guidance on classification, listings, site registration