FDA 510(k) Application Details - K221901

Device Classification Name Board, Cardiopulmonary

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510(K) Number K221901
Device Name Board, Cardiopulmonary
Applicant AdvancedCPR Solutions LLC
5201 Eden Avenue
Suite 300
Edina, MN 55436 US
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Contact Philip Faris
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Regulation Number 880.6080

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Classification Product Code FOA
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Date Received 06/30/2022
Decision Date 07/29/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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