K062457 is an FDA 510(k) clearance for the INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES. This device is classified as a Pump, Infusion, Elastomeric (Class II - Special Controls, product code MEB).
Submitted by Baxter Healthcare Corporation (Mcgaw Park, US). The FDA issued a Cleared decision on September 21, 2006, 29 days after receiving the submission on August 23, 2006.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K062457 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 2006 |
| Decision Date | September 21, 2006 |
| Days to Decision | 29 days |
| Submission Type | Special |
| 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 |