The following data is part of a premarket notification filed by Graftworx, Inc. Dba Alio with the FDA for Alio Medical Remote Monitoring System.
| Device ID | K211365 |
| 510k Number | K211365 |
| Device Name: | Alio Medical Remote Monitoring System |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | Graftworx, Inc. Dba Alio 544B Bryant Street San Francisco, CA 94107 |
| Contact | David Kuraguntla |
| Correspondent | Allison Komiyama AcKnowledge Regulatory Strategies, LLC 2251 San Diego Ave. Suite B-257 San Diego, CA 92109 |
| Product Code | DRG |
| Subsequent Product Code | DQD |
| Subsequent Product Code | FLL |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-04 |
| Decision Date | 2022-03-24 |