K842399 is an FDA 510(k) clearance for the 48 HOUR SET CHANGES. This device is classified as a Filter, Infusion Line (Class II - Special Controls, product code FPB).
Submitted by Tri-Med, Inc. (Huntington Beach, US). The FDA issued a Cleared decision on October 9, 1984, 112 days after receiving the submission on June 19, 1984.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K842399 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 1984 |
| Decision Date | October 09, 1984 |
| Days to Decision | 112 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 |