FDA 510(k) Application Details - K010526

Device Classification Name	Aid, Cardiopulmonary Resuscitation   More FDA Info for this Device
510(K) Number	K010526
Device Name	Aid, Cardiopulmonary Resuscitation
Applicant	ELCARE INNOVATIONS, INC. 7101 STEPHENSON-LEVEY RD. BURLESON, TX 76028 US Other 510(k) Applications for this Company
Contact	ELROY T CANTRELL Other 510(k) Applications for this Contact
Regulation Number	870.5200   More FDA Info for this Regulation Number
Classification Product Code	LIX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/22/2001
Decision Date	12/13/2001
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