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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 K844055
Device Name ESOPHAGEAL STETHO SCOPE
Applicant
Sensortek, Inc.
154 Huron Ave.
Clifton,  NJ  07013
Applicant Contact RONALD R FELLER
Correspondent
Sensortek, Inc.
154 Huron Ave.
Clifton,  NJ  07013
Correspondent Contact RONALD R FELLER
Regulation Number868.1920
Classification Product Code
BZT  
Date Received10/18/1984
Decision Date 10/25/1984
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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