The following data is part of a premarket notification filed by Wenzhou Xikang Medical Instruments Co., Ltd with the FDA for Wx Non-automated Blood Pressure Meter,model Wx02, Wx Non-automated Blood Pressure Meter With Stethoscope, Model Wx0201, Wx0202, Wx0203.
| Device ID | K212416 |
| 510k Number | K212416 |
| Device Name: | WX Non-Automated Blood Pressure Meter,MODEL WX02, WX Non-Automated Blood Pressure Meter With Stethoscope, MODEL WX0201, WX0202, WX0203 |
| Classification | Blood Pressure Cuff |
| Applicant | Wenzhou Xikang Medical Instruments Co., Ltd No.1478 Haining Road, Haibin Street, Longwan District Wenzhou, CN 325024 |
| Contact | Wang Tiance |
| Correspondent | Sandy Liu Jin Services Co. 9F-1, No13, Lane41, Zhangrong Rd, Sec. 5, North District Tainan City, TW 70447 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-03 |
| Decision Date | 2022-05-18 |