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510K

Application number that medical device manufacturers must file, to notify FDA of their intent to market a medical device at least 90 days in advance. Also known as Premarket Notification – PMN. This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, “new” devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified.(1)

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