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FDA 510(k) Application Details - K973839
Device Classification Name
Stethoscope, Esophageal, With Electrical Conductors
More FDA Info for this Device
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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More FDA Info for this Product Code
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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