The following data is part of a premarket notification filed by Imed Corp. with the FDA for Model Pc-2 Volumetric Infusion Pump/controller.
| Device ID | K862295 |
| 510k Number | K862295 |
| Device Name: | MODEL PC-2 VOLUMETRIC INFUSION PUMP/CONTROLLER |
| Classification | Pump, Infusion |
| Applicant | IMED CORP. 9775 BUSINESSPARK AVE. San Diego, CA 92131 -1699 |
| Contact | Ralph H Jarboe,phd |
| Correspondent | Ralph H Jarboe,phd IMED CORP. 9775 BUSINESSPARK AVE. San Diego, CA 92131 -1699 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-17 |
| Decision Date | 1986-09-23 |