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FDA 510(k) Application Details - K111693
Device Classification Name
Automated External Defibrillators (Non-Wearable)
More FDA Info for this Device
510(K) Number
K111693
Device Name
Automated External Defibrillators (Non-Wearable)
Applicant
PHILIPS MEDICAL SYSTEMS
2301 5TH AVENUE, SUITE 200
SEATTLE, WA 98121-1825 US
Other 510(k) Applications for this Company
Contact
TAMARA YOUNT
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
06/16/2011
Decision Date
10/28/2011
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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