MONOCRYSTANT PH/LES CATHETER, MODIFICATION

Monitor, Esophageal Motility, And Tube

SYNECTICS-DANTEC

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

Pre-market Notification Details

Device IDK914793
510k NumberK914793
Device Name:MONOCRYSTANT PH/LES CATHETER, MODIFICATION
ClassificationMonitor, Esophageal Motility, And Tube
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 CodeKLA  
CFR Regulation Number876.1725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-08-26
Decision Date1993-12-13

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