FDA 510(k) Application Details - K021168

Device Classification Name	Automated External Defibrillators (Non-Wearable)   More FDA Info for this Device
510(K) Number	K021168
Device Name	Automated External Defibrillators (Non-Wearable)
Applicant	MEDICAL RESEARCH LABORATORIES, INC. 1000 ASBURY DR. NO.17 BUFFALO GROVE, IL 60089 US Other 510(k) Applications for this Company
Contact	JOEL ORLINSKY 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	04/11/2002
Decision Date	06/26/2002
Decision	ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review