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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 K885347
Device Name VITACOMM MODEL #140/141 ESOPHAGEAL STETHOSCOPE
Applicant
VITACOMM, INC.
2324 N.BATAVIA #109
ORANGE,  CA  92665
Applicant Contact ROBERT L PFOHL
Correspondent
VITACOMM, INC.
2324 N.BATAVIA #109
ORANGE,  CA  92665
Correspondent Contact ROBERT L PFOHL
Regulation Number868.1920
Classification Product Code
BZT  
Date Received12/28/1988
Decision Date 01/30/1989
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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