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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 K874295
Device Name ESOPHAGEAL STETHOSCOPE W/ELECTRICAL CONDUCTORS
Applicant
Sheridan Catheter Corp.
Rte. 40
Argyle,  NY  12809
Applicant Contact STEEN, PH.D.
Correspondent
Sheridan Catheter Corp.
Rte. 40
Argyle,  NY  12809
Correspondent Contact STEEN, PH.D.
Regulation Number868.1920
Classification Product Code
BZT  
Date Received10/20/1987
Decision Date 11/24/1987
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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