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FDA 510(k) Application Details - K142709
Device Classification Name
Automated External Defibrillators (Non-Wearable)
More FDA Info for this Device
510(K) Number
K142709
Device Name
Automated External Defibrillators (Non-Wearable)
Applicant
HEARTSINE TECHNOLOGIES, INC.
121 Friends Lane
Suite 400
Newtown, PA 18940 US
Other 510(k) Applications for this Company
Contact
Paul Phillips
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
09/22/2014
Decision Date
03/27/2015
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
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