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FDA 510(k) Application Details - K131525
Device Classification Name
Automated External Defibrillators (Non-Wearable)
More FDA Info for this Device
510(K) Number
K131525
Device Name
Automated External Defibrillators (Non-Wearable)
Applicant
DEFIBTECH, LLC
741 BOSTON POST ROAD
GUILFORD, CT 06437 US
Other 510(k) Applications for this Company
Contact
Ed Horton
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
05/28/2013
Decision Date
04/24/2014
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
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