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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
510(k) Number K874519
Device Name MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR
Applicant
Mon-A-Therm, Inc.
St. Louis Business Center
500 S. Ewing Ave.
St. Louis,  MO  63103
Applicant Contact ALAN T BECKMAN
Correspondent
Mon-A-Therm, Inc.
St. Louis Business Center
500 S. Ewing Ave.
St. Louis,  MO  63103
Correspondent Contact ALAN T BECKMAN
Regulation Number868.1910
Classification Product Code
BZW  
Date Received11/02/1987
Decision Date 01/29/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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