The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for U-right Td-3128 Blood Pressure Monitoring System.
| Device ID | K112216 |
| 510k Number | K112216 |
| Device Name: | U-RIGHT TD-3128 BLOOD PRESSURE MONITORING SYSTEM |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | TaiDoc Technology Corporation 3F,5F, NO.127 WUGONG 2ND RD, WUGU DISTRICT New Taipei City, TW 24888 |
| Contact | Linda Ko |
| Correspondent | Linda Ko TaiDoc Technology Corporation 3F,5F, 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 | 2011-08-02 |
| Decision Date | 2011-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850065006437 | K112216 | 000 |
| 00850065006345 | K112216 | 000 |