K922382 is an FDA 510(k) clearance for the INTERMATE(R) LV ELASTOMERIC INFUSION DEVICE. This device is classified as a Pump, Infusion, Elastomeric (Class II - Special Controls, product code MEB).
Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on February 5, 1993, 261 days after receiving the submission on May 20, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K922382 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 1992 |
| Decision Date | February 05, 1993 |
| Days to Decision | 261 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MEB — Pump, Infusion, Elastomeric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |