The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Multigas Unit, Model Ag-920ra.
Device ID | K020046 |
510k Number | K020046 |
Device Name: | MULTIGAS UNIT, MODEL AG-920RA |
Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
Applicant | NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
Contact | Serrah Namini |
Correspondent | Serrah Namini NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
Product Code | CCK |
Subsequent Product Code | CBQ |
Subsequent Product Code | CBR |
Subsequent Product Code | CBS |
Subsequent Product Code | CCL |
Subsequent Product Code | NHO |
Subsequent Product Code | NHP |
Subsequent Product Code | NHQ |
CFR Regulation Number | 868.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-01-07 |
Decision Date | 2002-07-25 |
Summary: | summary |