PC POLYGRAF

Monitor, Esophageal Motility, And Tube

SYNECTICS-DANTEC

The following data is part of a premarket notification filed by Synectics-dantec with the FDA for Pc Polygraf.

Pre-market Notification Details

Device IDK872712
510k NumberK872712
Device Name:PC POLYGRAF
ClassificationMonitor, Esophageal Motility, And Tube
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 CodeKLA  
CFR Regulation Number876.1725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-07-10
Decision Date1988-03-18

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