FDA 510(k) Application Details - K071576

Device Classification Name	Electrode, Electrocardiograph   More FDA Info for this Device
510(K) Number	K071576
Device Name	Electrode, Electrocardiograph
Applicant	TEXTRONICS, INC 1835 MARKET STREET PHILADEPHIA, PA 19103 US Other 510(k) Applications for this Company
Contact	JANICE HOGAN 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	06/08/2007
Decision Date	11/02/2007
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