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 | K180240 |
| 510k Number | K180240 |
| 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 | J. S. Hsu |
| Correspondent | J. S. Hsu 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 | 2018-01-29 |
| Decision Date | 2018-10-17 |
| Summary: | summary |