K051253 is an FDA 510(k) clearance for the MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM). This device is classified as a Pump, Infusion, Pca (Class II - Special Controls, product code MEA).
Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on July 15, 2005, 60 days after receiving the submission on May 16, 2005.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K051253 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 2005 |
| Decision Date | July 15, 2005 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MEA — Pump, Infusion, Pca |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |