FDA 510(k) Application Details - K132758

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K132758
Device Name	Electrocardiograph
Applicant	SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD. P.O. BOX 120-119 SHANGHAI 200120 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	09/04/2013
Decision Date	01/30/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review