FDA 510(k) Application Details - K972418

Device Classification Name	Automated External Defibrillators (Non-Wearable)   More FDA Info for this Device
510(K) Number	K972418
Device Name	Automated External Defibrillators (Non-Wearable)
Applicant	HEARTSTREAM, INC. 2401 FOURTH AVE., SUITE 300 SEATTLE, WA 98121 US Other 510(k) Applications for this Company
Contact	CINDY PESTKA 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	06/27/1997
Decision Date	09/25/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review