ACCUMETER ELECTRONIC URINEMETER SYSTEM

Device, Urine Flow Rate Measuring, Non-electrical, Disposable

TRAVENOL LABORATORIES, S.A.

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

Pre-market Notification Details

Device IDK844030
510k NumberK844030
Device Name:ACCUMETER ELECTRONIC URINEMETER SYSTEM
ClassificationDevice, Urine Flow Rate Measuring, Non-electrical, Disposable
Applicant TRAVENOL LABORATORIES, S.A. Deerfield,  IL  60015
ContactJulia A Meyer
CorrespondentJulia A Meyer
TRAVENOL LABORATORIES, S.A. Deerfield,  IL  60015
Product CodeFFG  
CFR Regulation Number876.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-10-15
Decision Date1984-11-20

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