FDA 510(k) Application Details - K062020

Device Classification Name Stethoscope, Esophageal, With Electrical Conductors

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510(K) Number K062020
Device Name Stethoscope, Esophageal, With Electrical Conductors
Applicant NOVAMED, LLC
3460 POINTE CREEK CT. #102
BONITA SPRINGS, FL 34134-2015 US
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Contact PAUL DRYDEN
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Regulation Number 868.1920

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Classification Product Code BZT
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Date Received 07/17/2006
Decision Date 09/05/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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