AMBUL. PH & MOTILITY RECORDER FOR MEASURE OF PARA.

System, Gastrointestinal Motility (electrical)

SYNECTICS-DANTEC

The following data is part of a premarket notification filed by Synectics-dantec with the FDA for Ambul. Ph & Motility Recorder For Measure Of Para..

Pre-market Notification Details

Device IDK880581
510k NumberK880581
Device Name:AMBUL. PH & MOTILITY RECORDER FOR MEASURE OF PARA.
ClassificationSystem, Gastrointestinal Motility (electrical)
Applicant SYNECTICS-DANTEC 1425 GREENWAY DR. SUITE 600 Irving,  TX  75038
ContactMaria Lendau
CorrespondentMaria Lendau
SYNECTICS-DANTEC 1425 GREENWAY DR. SUITE 600 Irving,  TX  75038
Product CodeFFX  
CFR Regulation Number876.1725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-02-10
Decision Date1988-08-11

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