TRANSONIC SYRINGE WARMER, MODEL SYR-1000

System, Hemodialysis, Access Recirculation Monitoring

TRANSONIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Transonic Systems, Inc. with the FDA for Transonic Syringe Warmer, Model Syr-1000.

Pre-market Notification Details

Device IDK022963
510k NumberK022963
Device Name:TRANSONIC SYRINGE WARMER, MODEL SYR-1000
ClassificationSystem, Hemodialysis, Access Recirculation Monitoring
Applicant TRANSONIC SYSTEMS, INC. 34 DUTCH MILL RD. Ithaca,  NY  14850
ContactMark S Alsberge
CorrespondentMark S Alsberge
TRANSONIC SYSTEMS, INC. 34 DUTCH MILL RD. Ithaca,  NY  14850
Product CodeMQS  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-09-06
Decision Date2002-12-04
Summary:summary

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