FDA 510(k) Application Details - K973839

Device Classification Name Stethoscope, Esophageal, With Electrical Conductors

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510(K) Number K973839
Device Name Stethoscope, Esophageal, With Electrical Conductors
Applicant CATHETER RESEARCH, INC.
6131 WEST 80TH ST.
INDIANAPOLIS, IN 46278 US
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Contact JOHN A STEEN, PH.D.
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Regulation Number 868.1920

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Classification Product Code BZT
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Date Received 10/08/1997
Decision Date 03/19/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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