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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 K875369
Device Name MODEL ISO-2001 UNIV. PATIENT ISOLATION CIRCUIT
Applicant
Diamond Medical, Inc.
150 Eaton St.
St. Paul,  MN  55107
Applicant Contact RENELLE L NEAL
Correspondent
Diamond Medical, Inc.
150 Eaton St.
St. Paul,  MN  55107
Correspondent Contact RENELLE L NEAL
Regulation Number876.1400
Classification Product Code
FFT  
Date Received12/31/1987
Decision Date 02/05/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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