510(k) K033397

AVITA BPM6 SERIES BLOOD PRESSURE METER (OR MONITOR), MODEL BPM6XY by Avita Corporation — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2004
Date Received
October 24, 2003
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