The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora P100 Blood Pressure Monitoring System.
| Device ID | K182934 |
| 510k Number | K182934 |
| Device Name: | FORA P100 Blood Pressure Monitoring System |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | TaiDoc Technology Corporation 6F, No. 127, Wugong 2nd Rd., Wugu District New Taipei City, TW 24888 |
| Contact | Diana Sung |
| Correspondent | Sophia Wu TaiDoc Technology Corporation 6F, 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-22 |
| Decision Date | 2019-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816042014963 | K182934 | 000 |