GAS SAMPLING LINES

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

PROMEDIC, INC.

The following data is part of a premarket notification filed by Promedic, Inc. with the FDA for Gas Sampling Lines.

Pre-market Notification Details

Device IDK023579
510k NumberK023579
Device Name:GAS SAMPLING LINES
ClassificationAnalyzer, Gas, Carbon-dioxide, Gaseous-phase
Applicant PROMEDIC, INC. 6329 WEST WATERVIEW CT. Mccordsville,  IN  46055 -9501
ContactPaul Dryden
CorrespondentPaul Dryden
PROMEDIC, INC. 6329 WEST WATERVIEW CT. Mccordsville,  IN  46055 -9501
Product CodeCCK  
CFR Regulation Number868.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-10-24
Decision Date2003-01-28
Summary:summary

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