K833684 is an FDA 510(k) clearance for the IVEX-INT. This device is classified as a Filter, Infusion Line (Class II - Special Controls, product code FPB).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 27, 1983, 57 days after receiving the submission on October 31, 1983.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K833684 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 1983 |
| Decision Date | December 27, 1983 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FPB — Filter, Infusion Line |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |