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.
| Device ID | K944027 |
| 510k Number | K944027 |
| Device Name: | AG-839PA CO2 MODULE AND ACCESSORIES |
| Classification | Transducer, Gas Pressure |
| Applicant | NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine, CA 92612 -1601 |
| Contact | Penni Pannell |
| Correspondent | Penni Pannell NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine, CA 92612 -1601 |
| Product Code | BXO |
| CFR Regulation Number | 868.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-17 |
| Decision Date | 1994-08-31 |