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FDA 510(k) Application Details - K150055
Device Classification Name
Automated External Defibrillators (Non-Wearable)
More FDA Info for this Device
510(K) Number
K150055
Device Name
Automated External Defibrillators (Non-Wearable)
Applicant
BIO-DETEK, INC.
525 NARRAGANSETT PARK DR
PAWTUCKET, RI 02861 US
Other 510(k) Applications for this Company
Contact
CHUCK KOLIFRATH
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
01/12/2015
Decision Date
05/02/2015
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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