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FDA 510(k) Application Details - K013896
Device Classification Name
Automated External Defibrillators (Non-Wearable)
More FDA Info for this Device
510(K) Number
K013896
Device Name
Automated External Defibrillators (Non-Wearable)
Applicant
DEFIBTECH, LLC
1200 BOSTON POST RD.
SUITE 207
GUILFORD, CT 06437 US
Other 510(k) Applications for this Company
Contact
GINTARAS VAISNYS
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
11/23/2001
Decision Date
06/19/2002
Decision
ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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