510(k) K072860

YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-100J, BP-110J; DIGITAL WRIST BLOOD PRESSURE MONITOR, BP-500,BP-500 by Ya Horng Electronic Co., Ltd. — Product Code DXN

K072860 is an FDA 510(k) premarket notification submitted by Ya Horng Electronic Co., Ltd. for the device "YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-100J, BP-110J; DIGITAL WRIST BLOOD PRESSURE MONITOR, BP-500,BP-500". The FDA issued a decision of Substantially Equivalent on Feb 25, 2008. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Ya Horng Electronic Co., Ltd. has 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 25, 2008
Date Received
Oct 5, 2007
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)