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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Hemodialysis, Access Recirculation Monitoring
510(k) Number K980906
Device Name TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO
Applicant
Transonic Systems, Inc.
34 Dutch Mill Rd.
Ithaca,  NY  14850
Applicant Contact CORNELIS J DROST
Correspondent
Transonic Systems, Inc.
34 Dutch Mill Rd.
Ithaca,  NY  14850
Correspondent Contact CORNELIS J DROST
Regulation Number876.5820
Classification Product Code
MQS  
Date Received03/10/1998
Decision Date 10/06/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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