The following data is part of a premarket notification filed by Health & Life Co., Ltd with the FDA for Full Automatic(nibp) Blood Pressure Monitor.
| Device ID | K200521 |
| 510k Number | K200521 |
| Device Name: | Full Automatic(NIBP) Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Health & Life Co., Ltd 9F, No. 186 Jian Yi Road, Zhonghe District, New Taipei City, TW 23553 |
| Contact | Simon Lee |
| Correspondent | Simon Lee Health & Life Co., Ltd 9F, No. 186 Jian Yi Road, Zhonghe District, New Taipei City, TW 23553 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-02 |
| Decision Date | 2020-06-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10031262101577 | K200521 | 000 |
| 10031262101560 | K200521 | 000 |
| 10031262105025 | K200521 | 000 |
| 10875011006481 | K200521 | 000 |