510(k) K990031

NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES by Nihon Kohden America, Inc. — Product Code LOS

K990031 is an FDA 510(k) premarket notification submitted by Nihon Kohden America, Inc. for the device "NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on April 16, 1999. Nihon Kohden America, Inc. has at least 10 other 510(k) clearances on record.