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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Esophageal, With Electrical Conductors
510(k) Number K973839
Device Name DISPOSABLE ESOPHAGEAL STETHOSCOPE
Applicant
Catheter Research, Inc.
6131 W. 80th St.
Indianapolis,  IN  46278
Applicant Contact JOHN A STEEN, PH.D.
Correspondent
Catheter Research, Inc.
6131 W. 80th St.
Indianapolis,  IN  46278
Correspondent Contact JOHN A STEEN, PH.D.
Regulation Number868.1920
Classification Product Code
BZT  
Date Received10/08/1997
Decision Date 03/19/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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