K220695 is an FDA 510(k) clearance for the Elite Biomedical Solutions Dose Request Cord. This device is classified as a Accessories, Pump, Infusion (Class II - Special Controls, product code MRZ).
Submitted by Elite Biomedical Solutions (Cincinnati, US). The FDA issued a Cleared decision on April 29, 2022, 51 days after receiving the submission on March 9, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K220695 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 2022 |
| Decision Date | April 29, 2022 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MRZ - Accessories, Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |