510(k) K051368

BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM by Schiller AG — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 2005
Date Received
May 25, 2005
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