The following data is part of a premarket notification filed by United Health Group Inc. with the FDA for Optum Telehealth Application.
| Device ID | K171406 |
| 510k Number | K171406 |
| Device Name: | Optum TeleHealth Application |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | United Health Group Inc. 1100 King Street, Buliding 6, Suite 300 Rye Brook, NY 10573 |
| Contact | Donald J. Matthews |
| Correspondent | Donald J. Matthews United Health Group Inc. 1100 King Street, Buliding 6, Suite 300 Rye Brook, NY 10573 |
| Product Code | DRG |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DXN |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-12 |
| Decision Date | 2017-08-18 |
| Summary: | summary |