510(k) K881831

WS 800R THERMAL ARRAY RECORDER by Nihon Kohden America, Inc. — Product Code DSF

K881831 is an FDA 510(k) premarket notification submitted by Nihon Kohden America, Inc. for the device "WS 800R THERMAL ARRAY RECORDER". The FDA issued a decision of Substantially Equivalent on July 14, 1988. The device falls under product code DSF (Recorder, Paper Chart), a Class I device regulated under 21 CFR 870.2810. Nihon Kohden America, Inc. has at least 10 other 510(k) clearances on record.