K960512 is an FDA 510(k) clearance for the GEMINI PC-ITX. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Imed Corp. (San Diego, US). The FDA issued a Cleared decision on November 21, 1996, 290 days after receiving the submission on February 5, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K960512 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 1996 |
| Decision Date | November 21, 1996 |
| Days to Decision | 290 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |