FDA 510(k) Application Details - K102068

Device Classification Name Compressor, Cardiac, External

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510(K) Number K102068
Device Name Compressor, Cardiac, External
Applicant RESUSCITATION INTERNATIONAL
3722 AVE. SAUSALITO
IRVINE, CA 92606 US
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Contact ROBYN SCOPIS
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Regulation Number 870.5200

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Classification Product Code DRM
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Date Received 07/23/2010
Decision Date 11/16/2010
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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