AG-839PA CO2 MODULE AND ACCESSORIES

Transducer, Gas Pressure

NIHON KOHDEN AMERICA, INC.

The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Ag-839pa Co2 Module And Accessories.

Pre-market Notification Details

Device IDK944027
510k NumberK944027
Device Name:AG-839PA CO2 MODULE AND ACCESSORIES
ClassificationTransducer, Gas Pressure
Applicant NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine,  CA  92612 -1601
ContactPenni Pannell
CorrespondentPenni Pannell
NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine,  CA  92612 -1601
Product CodeBXO  
CFR Regulation Number868.2900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-08-17
Decision Date1994-08-31

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