FDA 510(k) Application Details - K081442

Device Classification Name	Dc-Defibrillator, Low-Energy, (Including Paddles)   More FDA Info for this Device
510(K) Number	K081442
Device Name	Dc-Defibrillator, Low-Energy, (Including Paddles)
Applicant	HEART SYNC LLC 5643 PLYMOUTH ROAD ANN ARBOR, MI 48105 US Other 510(k) Applications for this Company
Contact	STEPHEN SHULMAN Other 510(k) Applications for this Contact
Regulation Number	870.5300   More FDA Info for this Regulation Number
Classification Product Code	LDD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/22/2008
Decision Date	09/24/2008
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