MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT

Electrode, Ph, Stomach

SYNECTICS-DANTEC

The following data is part of a premarket notification filed by Synectics-dantec with the FDA for Modified Proxima Monitor/digitrapper Ed Unit.

Pre-market Notification Details

Device IDK902366
510k NumberK902366
Device Name:MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT
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 Received1990-05-16
Decision Date1990-06-08

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