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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 K811928
Device Name LIFESOUND ESOPHAGEAL STETHOSCOPE
Applicant
BIOMEDICAL CONCEPTS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
BIOMEDICAL CONCEPTS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.1920
Classification Product Code
BZT  
Date Received07/06/1981
Decision Date 07/28/1981
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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