BAXTER BEDSIDE SYSTEM

Pump, Infusion

TRAVENOL LABORATORIES, S.A.

The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Baxter Bedside System.

Pre-market Notification Details

Device IDK874181
510k NumberK874181
Device Name:BAXTER BEDSIDE SYSTEM
ClassificationPump, Infusion
Applicant TRAVENOL LABORATORIES, S.A. WILSON RD. AT ROUTE 120 P.O. BOX 490 Round Lake,  IL  60073
ContactDennis Ocwieja
CorrespondentDennis Ocwieja
TRAVENOL LABORATORIES, S.A. WILSON RD. AT ROUTE 120 P.O. BOX 490 Round Lake,  IL  60073
Product CodeFRN  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-10-14
Decision Date1988-02-22

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