The following data is part of a premarket notification filed by Truly Instrument Limited with the FDA for Truly Automatic Blood Pressure Monitor, Model Db11.
| Device ID | K081852 |
| 510k Number | K081852 |
| Device Name: | TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | TRULY INSTRUMENT LIMITED TRULY INDUSTRIAL AREA Shanwei City, Guangdong, CN 516600 |
| Contact | Yang Jianhao |
| Correspondent | Yang Jianhao TRULY INSTRUMENT LIMITED TRULY INDUSTRIAL AREA Shanwei City, Guangdong, CN 516600 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-30 |
| Decision Date | 2008-12-12 |