The following data is part of a premarket notification filed by Imed Corp. with the FDA for Imed(r) Gemini(tm) Pc-1 Volumetric Infusion Pump.
| Device ID | K880479 |
| 510k Number | K880479 |
| Device Name: | IMED(R) GEMINI(TM) PC-1 VOLUMETRIC INFUSION PUMP |
| Classification | Pump, Infusion |
| Applicant | IMED CORP. 9775 BUSINESSPARK AVE. San Diego, CA 92131 -1699 |
| Contact | Jarboe, Phd |
| Correspondent | 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 | 1988-02-05 |
| Decision Date | 1988-04-25 |