510(k) K061760

ARM BLOOD PRESSURE MONITOR, MODEL KP-7600 by K-Jump Health Co., Ltd. — Product Code DXN

K061760 is an FDA 510(k) premarket notification submitted by K-Jump Health Co., Ltd. for the device "ARM BLOOD PRESSURE MONITOR, MODEL KP-7600". The FDA issued a decision of Substantially Equivalent on August 14, 2006. 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
August 14, 2006
Date Received
June 22, 2006
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