510(k) K093872

HANDHELD ECG MONITOR, MODEL MD100 by Beijing Choice Electronic Technololgy Co., Ltd. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2010
Date Received
December 17, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type