The following data is part of a premarket notification filed by Zhangzhou Easepal Medical Science And Technology Co.,ltd with the FDA for Blood Pressure Monitor(model:y30001).
| Device ID | K213023 |
| 510k Number | K213023 |
| Device Name: | Blood Pressure Monitor(Model:Y30001) |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Zhangzhou Easepal Medical Science And Technology Co.,LTD West Of The 4th Floor,No7. Building,Easepal Factory, No.228, JiaoSong Road, Jiaomei Town Zhangzhou, CN 363000 |
| Contact | Yuehua Huang |
| Correspondent | Jett Lee Guangdong Jianda Medical Technology Co., Ltd. 906 Room, Longxiang Garden, Tianhe District Guangzhou, CN 510000 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-21 |
| Decision Date | 2022-09-30 |