The following data is part of a premarket notification filed by Arrayent Health Llc D/b/a Ambio Health with the FDA for Ambio Remote Health Monitoring System.
| Device ID | K130676 |
| 510k Number | K130676 |
| Device Name: | AMBIO REMOTE HEALTH MONITORING SYSTEM |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | ARRAYENT HEALTH LLC D/B/A AMBIO HEALTH 1266 EAST MAIN STREET SUITE 700R Stamford, CT 06902 |
| Contact | Kevin Jones |
| Correspondent | Kevin Jones ARRAYENT HEALTH LLC D/B/A AMBIO HEALTH 1266 EAST MAIN STREET SUITE 700R Stamford, CT 06902 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-12 |
| Decision Date | 2013-07-08 |
| Summary: | summary |