The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Vtrust Vital Signs Monitor, Model: Td-2300; Fora Vital Signs Monitor, Model: Vsm100.
| Device ID | K172221 |
| 510k Number | K172221 |
| Device Name: | VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100 |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | TaiDoc Technology Corporation 6F, No.127, Wugong 2nd Rd., Wugu District New Taipei City, TW 24888 |
| Contact | Anne Kuo |
| Correspondent | Anne Kuo TaiDoc Technology Corporation 6F, No.127, Wugong 2nd Rd., Wugu District New Taipei City, TW 24888 |
| Product Code | MWI |
| Subsequent Product Code | DPS |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| Subsequent Product Code | LFR |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-24 |
| Decision Date | 2018-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816042014314 | K172221 | 000 |
| 00816042014239 | K172221 | 000 |
| 00816042014215 | K172221 | 000 |
| 00816042014253 | K172221 | 000 |