510(k) K012020

RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PC by Non-Invasive Monitoring Systems, Inc. — Product Code DQK

K012020 is an FDA 510(k) premarket notification submitted by Non-Invasive Monitoring Systems, Inc. for the device "RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PC". The FDA issued a decision of Substantially Equivalent on August 21, 2001. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Non-Invasive Monitoring Systems, Inc. has at least 5 other 510(k) clearances on record.