The following data is part of a premarket notification filed by Joytech Healthcare Co.,ltd with the FDA for Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor.
| Device ID | K212115 |
| 510k Number | K212115 |
| Device Name: | Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | JOYTECH HEALTHCARE CO.,LTD No.365, Wuzhou Road, Yuhang Economic Development Zone, Hangzhou City Hangzhou, CN 311100 |
| Contact | Ren Yunhua |
| Correspondent | Ren Yunhua JOYTECH HEALTHCARE CO.,LTD No.365, Wuzhou Road, Yuhang Economic Development Zone, Hangzhou City Hangzhou, CN 311100 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-07 |
| Decision Date | 2022-01-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810038634395 | K212115 | 000 |