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 | K153214 |
| 510k Number | K153214 |
| 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 | Sarah Su |
| Correspondent | Sarah Su 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 | 2015-11-05 |
| Decision Date | 2016-01-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10311917183401 | K153214 | 000 |
| 14719872489112 | K153214 | 000 |
| 14719872489105 | K153214 | 000 |
| 14719872483028 | K153214 | 000 |
| 10311917207008 | K153214 | 000 |