FDA 510(k) Application Details - K955890

Device Classification Name	Automated External Defibrillators (Non-Wearable)   More FDA Info for this Device
510(K) Number	K955890
Device Name	Automated External Defibrillators (Non-Wearable)
Applicant	COLORADO MEDTECH, INC. 6175 LONGBOW DR. BOULDER, CO 80301 US Other 510(k) Applications for this Company
Contact	BONNIE J NORMAN Other 510(k) Applications for this Contact
Regulation Number	870.5310   More FDA Info for this Regulation Number
Classification Product Code	MKJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/29/1995
Decision Date	07/28/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review