FDA 510(k) Application Details - K983307

Device Classification Name	Automated External Defibrillators (Non-Wearable)   More FDA Info for this Device
510(K) Number	K983307
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	09/21/1998
Decision Date	11/20/1998
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