The following data is part of a premarket notification filed by International Medical Products, Inc. with the FDA for Nikkiso Infusion Pump Model Pfa-02.
| Device ID | K861539 |
| 510k Number | K861539 |
| Device Name: | NIKKISO INFUSION PUMP MODEL PFA-02 |
| Classification | Pump, Infusion |
| Applicant | INTERNATIONAL MEDICAL PRODUCTS, INC. 4503 MOORLAND AVE. Minneapolis, MN 55435 |
| Contact | Jeffrey R Shideman |
| Correspondent | Jeffrey R Shideman INTERNATIONAL MEDICAL PRODUCTS, INC. 4503 MOORLAND AVE. Minneapolis, MN 55435 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-24 |
| Decision Date | 1986-07-31 |