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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 K955298
Device Name PHOENIX DIALYSATE METER
Applicant
AUTOMATA MEDICAL INSTRUMENTATION, INC.
7830 EAST REDFIELD RD.,
SUITE 12
SCOTTSDALE,  AZ  85260
Applicant Contact LINDA V MASANO
Correspondent
AUTOMATA MEDICAL INSTRUMENTATION, INC.
7830 EAST REDFIELD RD.,
SUITE 12
SCOTTSDALE,  AZ  85260
Correspondent Contact LINDA V MASANO
Regulation Number876.5820
Classification Product Code
FIZ  
Date Received11/20/1995
Decision Date 02/29/1996
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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