The following data is part of a premarket notification filed by Imed Corp. with the FDA for Imed Model Pc-4 Volumetric Infusion Pump/controlle.
| Device ID | K921378 |
| 510k Number | K921378 |
| Device Name: | IMED MODEL PC-4 VOLUMETRIC INFUSION PUMP/CONTROLLE |
| Classification | Pump, Infusion |
| Applicant | IMED CORP. 9775 BUSINESSPARK AVE. San Diego, CA 92131 -1699 |
| Contact | Ralph Jarboe |
| Correspondent | Ralph Jarboe 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 | 1992-03-23 |
| Decision Date | 1992-06-09 |