FDA 510(k) Application Details - K023637

Device Classification Name Stethoscope, Electronic

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510(K) Number K023637
Device Name Stethoscope, Electronic
Applicant TYTAN MEDICAL CORP.
3892 SOUTH AMERICA WEST TRAIL
FLAGSTAFF, AZ 86001 US
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Contact JENNIFER REICH
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Regulation Number 870.1875

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Classification Product Code DQD
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Date Received 10/30/2002
Decision Date 02/26/2003
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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