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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 K864858
Device Name LIFESOUND(TM) ESOPHAGEAL STETHOSCOPE W/THERMISTOR
Applicant
Biomedical Concepts, Inc.
85 Executive Blvd.
Elmsford,  NY  10523
Applicant Contact JOHN R GRAHAM
Correspondent
Biomedical Concepts, Inc.
85 Executive Blvd.
Elmsford,  NY  10523
Correspondent Contact JOHN R GRAHAM
Regulation Number868.1920
Classification Product Code
BZT  
Date Received12/11/1986
Decision Date 03/10/1987
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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