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 | K190507 |
| 510k Number | K190507 |
| 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 | 2019-03-01 |
| Decision Date | 2019-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00311917208954 | K190507 | 000 |
| 10311917133048 | K190507 | 000 |
| 10311917133222 | K190507 | 000 |
| 00031262106650 | K190507 | 000 |
| 00031262106841 | K190507 | 000 |
| 10898302140121 | K190507 | 000 |
| 14719872483295 | K190507 | 000 |
| 14719872489167 | K190507 | 000 |
| 00850842006247 | K190507 | 000 |
| 10311917132850 | K190507 | 000 |