510(k) K200494

CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES by GE Healthcare — Product Code MHX

K200494 is an FDA 510(k) premarket notification submitted by GE Healthcare for the device "CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES". The FDA issued a decision of Substantially Equivalent on Mar 29, 2020. The device falls under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.1025. GE Healthcare has 168 other 510(k) clearances on record.