The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Ag-820pa Fi02 Module.
| Device ID | K896359 |
| 510k Number | K896359 |
| Device Name: | AG-820PA FI02 MODULE |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Contact | Paul Hasforth |
| Correspondent | Paul Hasforth NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-06 |
| Decision Date | 1990-03-09 |