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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrode, ph, stomach
510(k) Number K850778
Device Name SET -502T PH ESOPHAGEAL MICRO SIZE ELECTRODE
Applicant
SETTLER MEDICAL ELECTRONICS, INC.
723 QUEENSTON ST.
WINNIPEG,  CA
Correspondent
SETTLER MEDICAL ELECTRONICS, INC.
723 QUEENSTON ST.
WINNIPEG,  CA
Regulation Number876.1400
Classification Product Code
FFT  
Date Received02/26/1985
Decision Date 06/13/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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