The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora Telehealth System.
| Device ID | K083046 |
| 510k Number | K083046 |
| Device Name: | FORA TELEHEALTH SYSTEM |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 241 |
| Contact | Yuhua Chen |
| Correspondent | Yuhua Chen TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 241 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-14 |
| Decision Date | 2009-01-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816042014949 | K083046 | 000 |