K223073 is an FDA 510(k) clearance for the Alio. This device is classified as a Transmitters And Receivers, Physiological Signal, Radiofrequency (Class II - Special Controls, product code DRG).
Submitted by Alio, Inc. (Broomfield, US). The FDA issued a Cleared decision on March 17, 2023, 168 days after receiving the submission on September 30, 2022.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 870.2910.
| 510(k) Number | K223073 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2022 |
| Decision Date | March 17, 2023 |
| Days to Decision | 168 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | DRG - Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2910 |