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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 K853280
Device Name FOUR CHANNEL PH PROBE
Applicant
Akron City Hospital
Akron,  OH  44309
Applicant Contact VINCENT J GRECZANIK
Correspondent
Akron City Hospital
Akron,  OH  44309
Correspondent Contact VINCENT J GRECZANIK
Regulation Number876.1400
Classification Product Code
FFT  
Date Received08/05/1985
Decision Date 12/02/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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