FDA 510(k) Application Details - K220766

Device Classification Name Stethoscope, Electronic

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510(K) Number K220766
Device Name Stethoscope, Electronic
Applicant CSD Labs GmbH
Nikolaiplatz 4
Graz 8020 AT
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Contact Andreas Reinisch
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Regulation Number 870.1875

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Classification Product Code DQD
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Date Received 03/16/2022
Decision Date 05/31/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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