The following data is part of a premarket notification filed by Taiwan Scientific Corporation with the FDA for Answatch Wrist Monitor Model Ts-0411.
| Device ID | K123130 |
| 510k Number | K123130 |
| Device Name: | ANSWATCH WRIST MONITOR MODEL TS-0411 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | TAIWAN SCIENTIFIC CORPORATION 10F, 88-4, MING-CHIUAN RD, SHIN-DIAN DISTRIC New Taipei, TW 23141 |
| Contact | Dehchuan Sun |
| Correspondent | Dehchuan Sun TAIWAN SCIENTIFIC CORPORATION 10F, 88-4, MING-CHIUAN RD, SHIN-DIAN DISTRIC New Taipei, TW 23141 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-04 |
| Decision Date | 2013-09-17 |
| Summary: | summary |