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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
510(k) Number K844444
Device Name ESOPHAGEAL STETHOSCOPE
Applicant
MEDICAL PARAMETERS, INC.
20 CABOT RD.
WOBURN,  MA  01801
Applicant Contact WALTER MACEACHERN
Correspondent
MEDICAL PARAMETERS, INC.
20 CABOT RD.
WOBURN,  MA  01801
Correspondent Contact WALTER MACEACHERN
Regulation Number868.1910
Classification Product Code
BZW  
Date Received11/16/1984
Decision Date 01/10/1985
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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