The following data is part of a premarket notification filed by Biocare Corp. with the FDA for Vtrust Blood Pressure Monitor, Model Vtrust 701dh.
| Device ID | K091414 |
| 510k Number | K091414 |
| Device Name: | VTRUST BLOOD PRESSURE MONITOR, MODEL VTRUST 701DH |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | BIOCARE CORP. 4F, NO 12, LANE 5, SEC, 2 NANSHAN RD., LUJHU TOWNSHIP Taoyuan, TW 33852 |
| Contact | Judy Wei |
| Correspondent | Judy Wei BIOCARE CORP. 4F, NO 12, LANE 5, SEC, 2 NANSHAN RD., LUJHU TOWNSHIP Taoyuan, TW 33852 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-13 |
| Decision Date | 2009-10-21 |
| Summary: | summary |