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-hl158tb.
| Device ID | K190134 |
| 510k Number | K190134 |
| Device Name: | Full Automatic (NIBP) Blood Pressure Monitor-HL158TB |
| 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 | Js Hsu |
| Correspondent | Js 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-28 |
| Decision Date | 2019-05-20 |