The following data is part of a premarket notification filed by Optumhealth Care Solutions, Inc. with the FDA for Optum Telehealth Application.
| Device ID | K130971 |
| 510k Number | K130971 |
| Device Name: | OPTUM TELEHEALTH APPLICATION |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | OPTUMHEALTH CARE SOLUTIONS, INC. 4 INNOVATION DR Dundas, On, CA L9h 7p3 |
| Contact | Roshana Ahmed, Ma, Rac |
| Correspondent | Roshana Ahmed, Ma, Rac OPTUMHEALTH CARE SOLUTIONS, INC. 4 INNOVATION DR Dundas, On, CA L9h 7p3 |
| Product Code | DRG |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DXN |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-08 |
| Decision Date | 2013-10-23 |
| Summary: | summary |