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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 K934434
Device Name CYBERRX MODEL 7200
Applicant
Cybermed Control Systems, Inc.
12770 High Bluff Dr.
Suite 180
San Diego,  CA  92130
Applicant Contact MICHAEL S GOLDBERG
Correspondent
Cybermed Control Systems, Inc.
12770 High Bluff Dr.
Suite 180
San Diego,  CA  92130
Correspondent Contact MICHAEL S GOLDBERG
Regulation Number876.1400
Classification Product Code
FFT  
Date Received08/23/1993
Decision Date 01/24/1995
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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