510(k) K991688

WRIST TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-303S by Jawon Medical Co., Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1999
Date Received
May 17, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type