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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 K842309
Device Name VITACOMM 100 ESOPHAGEAL STETHOSCOPE
Applicant
VITACOMM, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
VITACOMM, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.1920
Classification Product Code
BZT  
Date Received06/12/1984
Decision Date 06/22/1984
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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