FDA 510(k) Application Details - K100315

Device Classification Name	Electrode, Electrocardiograph   More FDA Info for this Device
510(K) Number	K100315
Device Name	Electrode, Electrocardiograph
Applicant	I NEEDMD, INC 420 LEXINGTON AVENUE SUITE 2400 NEW YORK, NY 10170 US Other 510(k) Applications for this Company
Contact	IRVING L WIESEN, ESQ Other 510(k) Applications for this Contact
Regulation Number	870.2360   More FDA Info for this Regulation Number
Classification Product Code	DRX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/04/2010
Decision Date	04/23/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review