510(k) K092806

AUTO DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, MODEL KP-7770 by K-Jump Health Co., Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2009
Date Received
September 11, 2009
Clearance Type
Special
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