The following data is part of a premarket notification filed by Beijing Bywave Sensing Medical Technology Co., Ltd. with the FDA for Lipps Analyzer, Lipps Wire Pressure Guide Wire.
| Device ID | K201720 |
| 510k Number | K201720 |
| Device Name: | LiPPS Analyzer, LiPPS Wire Pressure Guide Wire |
| Classification | Wire, Guide, Catheter |
| Applicant | Beijing Bywave Sensing Medical Technology Co., Ltd. Room 501, Buildinctg 22, No.12, Juyuan Middle Road, Mapo Town, Shunyi District Beijing, CN 101399 |
| Contact | Lizhe Zhang |
| Correspondent | Lizhe Zhang Beijing Bywave Sensing Medical Technology Co., Ltd. Room 501, Buildinctg 22, No.12, Juyuan Middle Road, Mapo Town, Shunyi District Beijing, CN 101399 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-23 |
| Decision Date | 2021-02-18 |