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, Model Hl858dm.
| Device ID | K211127 |
| 510k Number | K211127 |
| Device Name: | Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM |
| 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 | Peggy Su |
| Correspondent | Peggy 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 | 2021-04-16 |
| Decision Date | 2021-09-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00031262106353 | K211127 | 000 |