MULTIGAS UNIT, MODEL AG-920RA

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

NIHON KOHDEN AMERICA, INC.

The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Multigas Unit, Model Ag-920ra.

Pre-market Notification Details

Device IDK020046
510k NumberK020046
Device Name:MULTIGAS UNIT, MODEL AG-920RA
ClassificationAnalyzer, Gas, Carbon-dioxide, Gaseous-phase
Applicant NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch,  CA  92610 -1601
ContactSerrah Namini
CorrespondentSerrah Namini
NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch,  CA  92610 -1601
Product CodeCCK  
Subsequent Product CodeCBQ
Subsequent Product CodeCBR
Subsequent Product CodeCBS
Subsequent Product CodeCCL
Subsequent Product CodeNHO
Subsequent Product CodeNHP
Subsequent Product CodeNHQ
CFR Regulation Number868.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-01-07
Decision Date2002-07-25
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.