510(k) K253196

Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) by Midmark Corporation — Product Code MWI

K253196 is an FDA 510(k) premarket notification submitted by Midmark Corporation for the device "Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)". The FDA issued a decision of Substantially Equivalent on June 12, 2026. The device falls under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.2300. Midmark Corporation has at least 5 other 510(k) clearances on record.