FDA 510(k) Application Details - K962551

Device Classification Name Dc-Defibrillator, Low-Energy, (Including Paddles)

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510(K) Number K962551
Device Name Dc-Defibrillator, Low-Energy, (Including Paddles)
Applicant MARQUETTE ELECTRONICS, INC.
8200 WEST TOWER AVE.
MILWAUKEE, WI 53223 US
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Contact KRISTIN PABST
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Regulation Number 870.5300

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Classification Product Code LDD
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Date Received 06/28/1996
Decision Date 11/19/1996
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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