510(k) K063814

BP-200 PLUS by Schiller AG — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2007
Date Received
December 22, 2006
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