510(k) K973613

CH-611B AND CH-611C DIGITAL WRIST SPHYGMOMANOMETERS BLOOD PRESSURE METER by Foley & Lardner — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1998
Date Received
September 22, 1997
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