510(k) K200738

Microlife Upper Arm Automatic Digital Blood Pressure Monitor by Microlife Intellectual Property GmbH — Product Code DXN

K200738 is an FDA 510(k) premarket notification submitted by Microlife Intellectual Property GmbH for the device "Microlife Upper Arm Automatic Digital Blood Pressure Monitor". The FDA issued a decision of Substantially Equivalent on July 23, 2020. 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
July 23, 2020
Date Received
March 23, 2020
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