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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14931921884949 | K020046 | 000 |
| 04931921131770 | K020046 | 000 |
| 10841983101592 | K020046 | 000 |
| 10841983101608 | K020046 | 000 |
| 10841983101615 | K020046 | 000 |
| 10841983101622 | K020046 | 000 |
| 14931921856885 | K020046 | 000 |
| 14931921856892 | K020046 | 000 |
| 14931921884932 | K020046 | 000 |
| 00841983103162 | K020046 | 000 |