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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name meter, conductivity, non-remote
510(k) Number K871708
Device Name NEO-I TEMPERATURE & CONDUCTIVITY METER
Applicant
AUTOMATA, INC.
4813 E. HILLERY DR.
SCOTTSDALE,  AZ  85254
Applicant Contact LINDA V MASANO
Correspondent
AUTOMATA, INC.
4813 E. HILLERY DR.
SCOTTSDALE,  AZ  85254
Correspondent Contact LINDA V MASANO
Regulation Number876.5820
Classification Product Code
FIZ  
Date Received05/01/1987
Decision Date 06/17/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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