ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF.

Electrode, Ph, Stomach

SYNECTICS-DANTEC

The following data is part of a premarket notification filed by Synectics-dantec with the FDA for Zinetics Composite Sensor Probe W/internal Ref..

Pre-market Notification Details

Device IDK925405
510k NumberK925405
Device Name:ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF.
ClassificationElectrode, Ph, Stomach
Applicant SYNECTICS-DANTEC 1425 GREENWAY DR. SUITE 600 Irving,  TX  75038
ContactAnna Pettersson
CorrespondentAnna Pettersson
SYNECTICS-DANTEC 1425 GREENWAY DR. SUITE 600 Irving,  TX  75038
Product CodeFFT  
CFR Regulation Number876.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-10-26
Decision Date1994-09-30

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