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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 K894757
Device Name T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE
Applicant
LOUISVILLE LABORATORIES, INC.
50 GOLDEN BALL RD.
WESTON,  MA  02193
Applicant Contact DAVID PHELPS
Correspondent
LOUISVILLE LABORATORIES, INC.
50 GOLDEN BALL RD.
WESTON,  MA  02193
Correspondent Contact DAVID PHELPS
Regulation Number868.1920
Classification Product Code
BZT  
Date Received07/27/1989
Decision Date 09/18/1989
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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