FDA 510(k) Application Details - K111438

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K111438
Device Name	Electrocardiograph
Applicant	REKA PTE LTD 1001 BEAR ISLAND ROAD SUITE 136 SUMMERVILLE, SC 29483 US Other 510(k) Applications for this Company
Contact	LARRY PETERSEN 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	05/24/2011
Decision Date	09/12/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review