FDA 510(k) Application Details - K122632

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K122632
Device Name	Electrocardiograph
Applicant	CARDIOCOMM SOLUTIONS, INC. 445 APOLLO BEACH BLVD. APOLLO BEACH, FL 33572 US Other 510(k) Applications for this Company
Contact	JONATHAN WARD 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	08/29/2012
Decision Date	02/11/2014
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