510(k) K884937

BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING by Grass-Telefactor Product Group — Product Code EEG

K884937 is an FDA 510(k) premarket notification submitted by Grass-Telefactor Product Group for the device "BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING". The FDA issued a decision of Substantially Equivalent on April 14, 1989. The device falls under product code EEG (Heat Source For Bleaching Teeth), a Class I device regulated under 21 CFR 872.6475. Grass-Telefactor Product Group has at least 10 other 510(k) clearances on record.