510(k) K142088

DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIES by Grandway Technology (Shenzhen) Limited — Product Code DXN

K142088 is an FDA 510(k) premarket notification submitted by Grandway Technology (Shenzhen) Limited for the device "DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIES". The FDA issued a decision of Substantially Equivalent on Oct 31, 2014. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Grandway Technology (Shenzhen) Limited has 20 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 31, 2014
Date Received
Aug 1, 2014
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
510(k)