FDA 510(k) Application Details - K981802

Device Classification Name	Automated External Defibrillators (Non-Wearable)   More FDA Info for this Device
510(K) Number	K981802
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	05/21/1998
Decision Date	11/25/1998
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