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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 K870255
Device Name MODIFIED TRACHEAL TUBE WITH SALTZMAN E.A.R.(TM)
Applicant
Transcor, Inc.
630 Oakwood Ave.
Suite 438
West Hartford,  CT  06110
Applicant Contact SALTZMAN M.D.
Correspondent
Transcor, Inc.
630 Oakwood Ave.
Suite 438
West Hartford,  CT  06110
Correspondent Contact SALTZMAN M.D.
Regulation Number868.1920
Classification Product Code
BZT  
Date Received01/22/1987
Decision Date 03/26/1987
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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