FDA 510(k) Application Details - K080933

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K080933
Device Name	Electrocardiograph
Applicant	BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. SUITE 8D ZHONGXIN ZHONGSHAN MANSION, NO. 19, LANE 999 SHANGHAI 20020 CN Other 510(k) Applications for this Company
Contact	Diana Hong Other 510(k) Applications for this Contact
Regulation Number	870.2340   More FDA Info for this Regulation Number
Classification Product Code	DPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/02/2008
Decision Date	09/26/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review