The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for U-right Td-3124 Blood Pressure Monitoring System.
| Device ID | K120634 |
| 510k Number | K120634 |
| Device Name: | U-RIGHT TD-3124 BLOOD PRESSURE MONITORING SYSTEM |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU DISTRICT New Taipei City, TW 24888 |
| Contact | Pinjung Chen |
| Correspondent | Pinjung Chen TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU DISTRICT New Taipei City, TW 24888 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-01 |
| Decision Date | 2012-07-03 |
| Summary: | summary |