The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Tfv-2300 Infusion Pump.
| Device ID | K890736 |
| 510k Number | K890736 |
| Device Name: | TFV-2300 INFUSION PUMP |
| Classification | Pump, Infusion |
| Applicant | NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Contact | Paul D Hasforth |
| Correspondent | Paul D Hasforth NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-13 |
| Decision Date | 1990-07-09 |