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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 K862536
Device Name MODEL 1010 AMBULATORY PH MONITORING SYSTEM
Applicant
Oxford Medilog, Inc.
11526 53rd. St. N.
Clearwater,  FL  33520
Applicant Contact MICHAEL J SMITH
Correspondent
Oxford Medilog, Inc.
11526 53rd. St. N.
Clearwater,  FL  33520
Correspondent Contact MICHAEL J SMITH
Regulation Number876.1400
Classification Product Code
FFT  
Date Received07/02/1986
Decision Date 09/12/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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