The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Blood Pressure Monitor, Model Fora P11/td-3019.
| Device ID | K091897 |
| 510k Number | K091897 |
| Device Name: | BLOOD PRESSURE MONITOR, MODEL FORA P11/TD-3019 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-24 |
| Decision Date | 2009-08-25 |