510(k) K092806

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

K092806 is an FDA 510(k) premarket notification submitted by K-Jump Health Co., Ltd. for the device "AUTO DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, MODEL KP-7770". The FDA issued a decision of Substantially Equivalent on October 9, 2009. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. K-Jump Health Co., Ltd. has at least 10 other 510(k) clearances on record.

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