FDA 510(k) Application Details - K990809

Device Classification Name Stethoscope, Electronic

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510(K) Number K990809
Device Name Stethoscope, Electronic
Applicant CADITEC AG
ONE MEDICAL PLACE
MUNDELEIN, IL 60060 US
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Contact BETTY LOCK
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Regulation Number 870.1875

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Classification Product Code DQD
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Date Received 03/11/1999
Decision Date 06/09/1999
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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