The following data is part of a premarket notification filed by Entra Health Systems with the FDA for Myhealthpoint Telehealth Manager.
| Device ID | K132930 |
| 510k Number | K132930 |
| Device Name: | MYHEALTHPOINT TELEHEALTH MANAGER |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | ENTRA HEALTH SYSTEMS 3111 Camino Del Rio North Suite 101 San Diego, CA 92108 |
| Contact | Richard Strobridge |
| Correspondent | Richard Strobridge ENTRA HEALTH SYSTEMS 3111 Camino Del Rio North Suite 101 San Diego, CA 92108 |
| Product Code | DRG |
| Subsequent Product Code | DPS |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRX |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| Subsequent Product Code | JQP |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-18 |
| Decision Date | 2014-04-14 |
| Summary: | summary |