510(k) K021305

MICROLIFE WRIST WATCH BLOOD PRESSURE, MODEL BP-3BU1-5, WITH OPTIONAL THERMAL PRINTER by Microlife Corp. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2002
Date Received
April 24, 2002
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