SYNDEO PCA SYRINGE PUMP, MODEL 2L3113

Pump, Infusion, Pca

BAXTER HEALTHCARE CORP.

The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Syndeo Pca Syringe Pump, Model 2l3113.

Pre-market Notification Details

Device IDK031566
510k NumberK031566
Device Name:SYNDEO PCA SYRINGE PUMP, MODEL 2L3113
ClassificationPump, Infusion, Pca
Applicant BAXTER HEALTHCARE CORP. ONE BAXTER PKWY. Deerfield,  IL  60015
ContactJennifer M Paine
CorrespondentJennifer M Paine
BAXTER HEALTHCARE CORP. ONE BAXTER PKWY. Deerfield,  IL  60015
Product CodeMEA  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-05-19
Decision Date2003-08-19
Summary:summary

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