Guangzhou Zhengkang Medical Equipment Co.,Ltd · Class II · Cleared Nov 5, 2021
| K-number | K212460 |
| Device name | Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) |
| Applicant | Guangzhou Zhengkang Medical Equipment Co.,Ltd |
| Product code | FXX |
| Device class | Class II |
| Decision date | Nov 5, 2021 |
| Decision | Substantially Equivalent |
| Regulation | 878.4040 |
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