FDA 510(k) Application Details - K130439

Device Classification Name	Device, Counter-Pulsating, External   More FDA Info for this Device
510(K) Number	K130439
Device Name	Device, Counter-Pulsating, External
Applicant	CHONGQING PSK SCI-TECH DEVELOPMENT CO., LTD 05C. FUHAI KANGLE BUILDING NANSHAN DISTRICT SHENZHEN, CHINA SHENZHEN, GUANGDONG 518000 CN Other 510(k) Applications for this Company
Contact	FIELD FU Other 510(k) Applications for this Contact
Regulation Number	870.5225   More FDA Info for this Regulation Number
Classification Product Code	DRN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/21/2013
Decision Date	12/12/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review