K192860 is an FDA 510(k) clearance for the Sapphire Infusion Pump, Sapphire administration sets. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Q Core Medical , Ltd. (Netanya, IL). The FDA issued a Cleared decision on November 19, 2020, 412 days after receiving the submission on October 4, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K192860 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 2019 |
| Decision Date | November 19, 2020 |
| Days to Decision | 412 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRN - Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |