510(k) K060703

PMP4 BP PRO BLOOD PRESSURE MONITOR by Card Guard Scientific Survival , Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2006
Date Received
March 16, 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