FDA 510(k) Application Details - K240162

Device Classification Name Auxillary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator

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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
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Regulation Number 870.5300

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Classification Product Code MPD
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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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