The following data is part of a premarket notification filed by Guangzhou Zhengkang Medical Equipment Co.,ltd with the FDA for Medical Surgical Mask (model: Zkm-u01(non-sterilized Type 17.5cm×9.5cm)).
| Device ID | K212460 |
| 510k Number | K212460 |
| Device Name: | Medical Surgical Mask (Model: ZKM-U01(non-sterilized Type 17.5cm×9.5cm)) |
| Classification | Mask, Surgical |
| Applicant | Guangzhou ZhengKang Medical Equipment Co.,Ltd Room101,No.9Nanling Zhongxin Kuang Road,Taihe Town Baiyun District Guangzhou, CN 510540 |
| Contact | Mike Wu |
| Correspondent | Tracy Che Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90 Qianhai Road Shenzhen, CN 518052 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-05 |
| Decision Date | 2021-11-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973824915680 | K212460 | 000 |