Galvanic Skin Response Measurement Devices Draft Guidance for 510(K) Content

摘要

This guidance is to be used in conjunction with the Division of Cardiovascular,Respiratory and Neurological Devices 'Draft Guidance for Format and Content for Premarket Notification 510(k)', which provides general guidance for preparing a '510(k)' premarket notification. Its purpose is to provide specific applicable to 510(k)s that claim equivalence to Galvanic Skin Response measurement (GSR) devices.