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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 K861541
Device Name SHERIDAN - YSI/ECG SONATEMP (TM)
Applicant
SHERIDAN CATHETER CORP.
ROUTE 40
ARGYLE,  NY  12809
Applicant Contact STEEN, PH.D.
Correspondent
SHERIDAN CATHETER CORP.
ROUTE 40
ARGYLE,  NY  12809
Correspondent Contact STEEN, PH.D.
Regulation Number868.1920
Classification Product Code
BZT  
Date Received04/24/1986
Decision Date 06/16/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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