The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for U-right Td-3127 Blood Pressure Monitoring System.
| Device ID | K100658 |
| 510k Number | K100658 |
| Device Name: | U-RIGHT TD-3127 BLOOD PRESSURE MONITORING SYSTEM |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | TaiDoc Technology Corporation 3F, 5F, NO 127 WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 248 |
| Contact | Nicky Pan |
| Correspondent | Nicky Pan TaiDoc Technology Corporation 3F, 5F, NO 127 WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 248 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-08 |
| Decision Date | 2010-07-09 |
| Summary: | summary |