510(k) K172498

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y by Microlife Intellectual Property GmbH — Product Code DXN

K172498 is an FDA 510(k) premarket notification submitted by Microlife Intellectual Property GmbH for the device "Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y". The FDA issued a decision of Substantially Equivalent on October 13, 2017. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Microlife Intellectual Property GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2017
Date Received
August 18, 2017
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