PH ANALYSIS MODULE

Electrode, Ph, Stomach

SYNECTICS-DANTEC

The following data is part of a premarket notification filed by Synectics-dantec with the FDA for Ph Analysis Module.

Pre-market Notification Details

Device IDK961346
510k NumberK961346
Device Name:PH ANALYSIS MODULE
ClassificationElectrode, Ph, Stomach
Applicant SYNECTICS-DANTEC RENSTIENAS GATA 12, 5TR. S-116 28 STOCKHOLM Sweden,  SE S-116 28
ContactAnn Pettersson
CorrespondentAnn Pettersson
SYNECTICS-DANTEC RENSTIENAS GATA 12, 5TR. S-116 28 STOCKHOLM Sweden,  SE S-116 28
Product CodeFFT  
CFR Regulation Number876.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-03-15
Decision Date1997-01-29
Summary:summary

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