510(k) K202372

Upper Arm Electronic Blood Pressure Monitor by Conmo Electronic Company Limited — Product Code DXN

K202372 is an FDA 510(k) premarket notification submitted by Conmo Electronic Company Limited for the device "Upper Arm Electronic Blood Pressure Monitor". The FDA issued a decision of Substantially Equivalent on December 30, 2020. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Conmo Electronic Company Limited has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 2020
Date Received
August 19, 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