BAXTER SINGLE PATIENT USE PRESSURE INFUSOR

Infusor, Pressure, For I.v. Bags

TECNADYNE SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Tecnadyne Scientific, Inc. with the FDA for Baxter Single Patient Use Pressure Infusor.

Pre-market Notification Details

Device IDK904484
510k NumberK904484
Device Name:BAXTER SINGLE PATIENT USE PRESSURE INFUSOR
ClassificationInfusor, Pressure, For I.v. Bags
Applicant TECNADYNE SCIENTIFIC, INC. 740C FOURTEENTH ST. Vero Beach,  FL  32960
ContactJohn Garrett
CorrespondentJohn Garrett
TECNADYNE SCIENTIFIC, INC. 740C FOURTEENTH ST. Vero Beach,  FL  32960
Product CodeKZD  
CFR Regulation Number880.5420 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-10-02
Decision Date1990-10-26

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