K983294 is an FDA 510(k) clearance for the ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122, 2B8132, 2B8142, 2B712. This device is classified as a Container, I.v. (Class II - Special Controls, product code KPE).
Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on November 3, 1998, 43 days after receiving the submission on September 21, 1998.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5025.
| 510(k) Number | K983294 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 21, 1998 |
| Decision Date | November 03, 1998 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KPE — Container, I.v. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5025 |