RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM

Pump, Infusion, Analytical Sampling

METRACOR TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Metracor Technologies, Inc. with the FDA for Roda (real Time Oxygen Dynamics Analysis) Monitoring System.

Pre-market Notification Details

Device IDK011238
510k NumberK011238
Device Name:RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM
ClassificationPump, Infusion, Analytical Sampling
Applicant METRACOR TECHNOLOGIES, INC. 11425 SORRENTO VALLEY RD. San Diego,  CA  92121
ContactGeorge F Mchugh
CorrespondentGeorge F Mchugh
METRACOR TECHNOLOGIES, INC. 11425 SORRENTO VALLEY RD. San Diego,  CA  92121
Product CodeLZF  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-04-23
Decision Date2002-01-08

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