The following data is part of a premarket notification filed by Anrei Medical (hangzhou) Co., Ltd. with the FDA for Single Use Endoscope Valves Set.
| Device ID | K192048 |
| 510k Number | K192048 |
| Device Name: | Single Use Endoscope Valves Set |
| Classification | Endoscope Channel Accessory |
| Applicant | Anrei Medical (Hangzhou) Co., Ltd. No. 3 Ave 8, HEDA Hangzhou, CN 310018 |
| Contact | Yang Huibing |
| Correspondent | Ray Wang Beijing Believe-Med Technology Service Co., Ltd. R912, B#15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, CN 102401 |
| Product Code | ODC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-31 |
| Decision Date | 2020-05-14 |