510(k) K242352

Accurate Mini Non-invasive blood pressure monitor (AMB-001) by Accurate Meditech, Inc. — Product Code DXN

K242352 is an FDA 510(k) premarket notification submitted by Accurate Meditech, Inc. for the device "Accurate Mini Non-invasive blood pressure monitor (AMB-001)". The FDA issued a decision of Substantially Equivalent on February 5, 2025. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Accurate Meditech, Inc. has at least 1 other 510(k) clearance on record.