FDA 510(k) Application Details - K142803

Device Classification Name	Automated External Defibrillators (Non-Wearable)   More FDA Info for this Device
510(K) Number	K142803
Device Name	Automated External Defibrillators (Non-Wearable)
Applicant	Leonhard Lang GmbH Archenweg 56 Innsbruck 6020 AT Other 510(k) Applications for this Company
Contact	Burrhus Lang 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	09/29/2014
Decision Date	12/02/2014
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