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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 K893409
Device Name YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMP
Applicant
Yellow Springs Instrument Co., Inc.
1725 Brannum Ln.
Yellow Springs,  OH  45387
Applicant Contact FRED BREIDT
Correspondent
Yellow Springs Instrument Co., Inc.
1725 Brannum Ln.
Yellow Springs,  OH  45387
Correspondent Contact FRED BREIDT
Regulation Number868.1920
Classification Product Code
BZT  
Date Received05/10/1989
Decision Date 07/20/1989
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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