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 | K142968 |
| 510k Number | K142968 |
| 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 | 2014-10-14 |
| Decision Date | 2014-12-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14719872489082 | K142968 | 000 |