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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 K871282
Device Name SYNECTICS LIBERTY SYSTEM AMPLIFIER AND SOFTWARE
Applicant
Synectics-Dantec
611 N. Broadway, Suite 412
Add Info To K872712
Milwaukee,  WI  53202
Applicant Contact ANDERS ESSEN-MOLLER
Correspondent
Synectics-Dantec
611 N. Broadway, Suite 412
Add Info To K872712
Milwaukee,  WI  53202
Correspondent Contact ANDERS ESSEN-MOLLER
Regulation Number876.1400
Classification Product Code
FFT  
Date Received03/31/1987
Decision Date 06/10/1987
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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