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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Blood Circuit, Hemodialysis
510(k) Number K002372
Device Name ACCESS ALERT GAUGE
Applicant
Medisystems Corp.
1201 3rd Ave.
Seattle,  WA  98101
Applicant Contact FREDRIC SWINDLER
Correspondent
Medisystems Corp.
1201 3rd Ave.
Seattle,  WA  98101
Correspondent Contact FREDRIC SWINDLER
Regulation Number876.5820
Classification Product Code
KOC  
Date Received08/04/2000
Decision Date 10/25/2000
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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