The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora Gw 9014 Telehealth Gateway/td-9014 Telehealth Gateway.
| Device ID | K100427 |
| 510k Number | K100427 |
| Device Name: | FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 24888 |
| Contact | Teling Hsu |
| Correspondent | Teling Hsu TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 24888 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-16 |
| Decision Date | 2010-05-28 |
| Summary: | summary |