510(k) K870381

DD-VCR-64 by Grass-Telefactor Product Group — Product Code GWK

K870381 is an FDA 510(k) premarket notification submitted by Grass-Telefactor Product Group for the device "DD-VCR-64". The FDA issued a decision of Substantially Equivalent on March 25, 1987. The device falls under product code GWK (Conditioner, Signal, Physiological), a Class II device regulated under 21 CFR 882.1845. Grass-Telefactor Product Group has at least 10 other 510(k) clearances on record.