The following data is part of a premarket notification filed by Digibio Technology Corp. with the FDA for Digibio Digtial Blood Pressure Monitor Model D11.
| Device ID | K014141 |
| 510k Number | K014141 |
| Device Name: | DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | DIGIBIO TECHNOLOGY CORP. 6833 SAINT LAWRENCE ST. Plano, TX 75024 |
| Contact | Eric Luo |
| Correspondent | Eric Luo DIGIBIO TECHNOLOGY CORP. 6833 SAINT LAWRENCE ST. Plano, TX 75024 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-17 |
| Decision Date | 2002-09-13 |