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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 K791190
Device Name STETHOSCOPE WITH TEMPERATURE SENSOR
Applicant
NATIONAL CATHETER CO. DIV. MALLINCKRODT
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
NATIONAL CATHETER CO. DIV. MALLINCKRODT
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.1920
Classification Product Code
BZT  
Date Received06/26/1979
Decision Date 07/06/1979
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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