K172653 is an FDA 510(k) clearance for the Power Infuser. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by ZOLL Medical Corporation (Chelsmford, US). The FDA issued a Cleared decision on July 18, 2018, 316 days after receiving the submission on September 5, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K172653 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 2017 |
| Decision Date | July 18, 2018 |
| Days to Decision | 316 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 |