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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, esophageal motility, anorectal motility, and tube
510(k) Number K882551
Device Name AMBULATORY PH DATA RECORDER SYSTEM, APH-2000
Applicant
INTL. BIOMEDICS, INC.
7651 AIRPORT BLVD.
HOUSTON,  TX  77061
Applicant Contact BENNO L DUNN
Correspondent
INTL. BIOMEDICS, INC.
7651 AIRPORT BLVD.
HOUSTON,  TX  77061
Correspondent Contact BENNO L DUNN
Regulation Number876.1725
Classification Product Code
KLA  
Date Received06/21/1988
Decision Date 10/12/1988
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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