Nephros Inc (NEPH)

[sterlingkuning]

What is Substantial Equivalence?
explained: http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/default.htm#se

To acquire clearance to market a device using the 510(k) pathway, the submitter of the 510(k) must show that the medical device is "substantially equivalent" to a device that is already legally marketed for the same use.