SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E

Electrode, Ph, Stomach

SYNECTICS-DANTEC

The following data is part of a premarket notification filed by Synectics-dantec with the FDA for Synectics Ph Sys Comprising Digitrapper Mark Ii, E.

Pre-market Notification Details

Device IDK850361
510k NumberK850361
Device Name:SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E
ClassificationElectrode, Ph, Stomach
Applicant SYNECTICS-DANTEC 333 N. MICHIGAN AVE. #2315 Chicago,  IL  60601
ContactAnders Essen-moller
CorrespondentAnders Essen-moller
SYNECTICS-DANTEC 333 N. MICHIGAN AVE. #2315 Chicago,  IL  60601
Product CodeFFT  
CFR Regulation Number876.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-01-30
Decision Date1985-05-01

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