K192647 is an FDA 510(k) clearance for the neria guard Infusion Set. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Unomedical A/S (Osted, DK). The FDA issued a Cleared decision on December 13, 2019, 80 days after receiving the submission on September 24, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K192647 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2019 |
| Decision Date | December 13, 2019 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPA - Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |