The following data is part of a premarket notification filed by Truly Instrument Ltd. with the FDA for Automatic Wrist Bluetooth Blood Pressure Monitor.
| Device ID | K170545 |
| 510k Number | K170545 |
| Device Name: | Automatic Wrist Bluetooth Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Truly Instrument Ltd. Site 2, Truly Industry Area Shanwei, CN 516600 |
| Contact | Yang Jian-hao |
| Correspondent | Max Wong Truly (U.S.A) Inc 2620 Concord Avenue Suite 106 Alhambra, CA 91801 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-24 |
| Decision Date | 2017-11-21 |
| Summary: | summary |