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FDA 510(k) Application Details - K240162
Device Classification Name
Auxillary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator
More FDA Info for this Device
510(K) Number
K240162
Device Name
Auxillary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator
Applicant
Stryker Physio-Control
11811 Willows Road NE
Redmond, WA 98052 US
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Contact
Roshonda Knight
Other 510(k) Applications for this Contact
Regulation Number
870.5300
More FDA Info for this Regulation Number
Classification Product Code
MPD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/22/2024
Decision Date
04/19/2024
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
FDA Source Information for K240162
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