K201634 is an FDA 510(k) clearance for the RG 3ml Medication Cartridge. This device is classified as a Accessories, Pump, Infusion (Class II - Special Controls, product code MRZ).
Submitted by Chengdu Shifeng Medical Technology Co., Ltd. (Jinhua Town, Xinjin County, CN). The FDA issued a Cleared decision on March 26, 2021, 283 days after receiving the submission on June 16, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K201634 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 2020 |
| Decision Date | March 26, 2021 |
| Days to Decision | 283 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 |