The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for U-right Td-3132 Blood Pressure Monitor, Fora P 20 Blood Pressure Monitor, Model Td-3132, Td-3132.
| Device ID | K092106 |
| 510k Number | K092106 |
| Device Name: | U-RIGHT TD-3132 BLOOD PRESSURE MONITOR, FORA P 20 BLOOD PRESSURE MONITOR, MODEL TD-3132, TD-3132 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 24888 |
| Contact | Erica Li |
| Correspondent | Erica Li TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 24888 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-14 |
| Decision Date | 2010-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816042011788 | K092106 | 000 |
| 00816042014857 | K092106 | 000 |
| 00816042014840 | K092106 | 000 |
| 00816042014833 | K092106 | 000 |
| 00816042014826 | K092106 | 000 |