The following data is part of a premarket notification filed by Truly Instrument Limited with the FDA for Arm Blood Pressure Monitor.
| Device ID | K192023 |
| 510k Number | K192023 |
| Device Name: | Arm Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Truly Instrument Limited Site 2, Truly Industry Area Shanwei, CN 516600 |
| Contact | Su Haisen |
| Correspondent | Max Wong TRULY (U.S.A) INC 2620 Concord Avenue, Suite 106 Alhambra, CA 91803 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-29 |
| Decision Date | 2019-12-23 |
| Summary: | summary |