510(k) K230184

Holter ECG and ABP System by Edan Instruments, Inc. — Product Code DSH

K230184 is an FDA 510(k) premarket notification submitted by Edan Instruments, Inc. for the device "Holter ECG and ABP System". The FDA issued a decision of Substantially Equivalent on September 25, 2023. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Edan Instruments, Inc. has at least 10 other 510(k) clearances on record.