510(k) K251120

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B) by Microlife Corporation — Product Code DXN

K251120 is an FDA 510(k) premarket notification submitted by Microlife Corporation for the device "Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B)". The FDA issued a decision of Substantially Equivalent on August 6, 2025. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2025
Date Received
April 11, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type