FDA 510(k) Application Details - K990106

Device Classification Name	Automated External Defibrillators (Non-Wearable)   More FDA Info for this Device
510(K) Number	K990106
Device Name	Automated External Defibrillators (Non-Wearable)
Applicant	BIO-DETEK, INC. 525 NARRAGANSETT PARK DR. PAWTUCKET, RI 02861-4323 US Other 510(k) Applications for this Company
Contact	MICHAEL R DUPELLE 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	01/12/1999
Decision Date	02/26/1999
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