MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION

Electrode, Ph, Stomach

SYNECTICS-DANTEC

The following data is part of a premarket notification filed by Synectics-dantec with the FDA for Monocrystant Ph-reference Catheter, Modification.

Pre-market Notification Details

Device IDK913817
510k NumberK913817
Device Name:MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION
ClassificationElectrode, Ph, Stomach
Applicant SYNECTICS-DANTEC RENSTIENAS GATA 12, 5TR. S-116 28 STOCKHOLM Sweden,  SE S-116 28
ContactAnna Pettersson
CorrespondentAnna 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 Received1991-08-26
Decision Date1992-06-11

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