K212957 is an FDA 510(k) clearance for the BioButton System. This device is classified as a Transmitters And Receivers, Physiological Signal, Radiofrequency (Class II - Special Controls, product code DRG).
Submitted by Biolntellisense, Inc. (Redwood City, US). The FDA issued a Cleared decision on December 12, 2022, 452 days after receiving the submission on September 16, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2910.
| 510(k) Number | K212957 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 2021 |
| Decision Date | December 12, 2022 |
| Days to Decision | 452 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRG - Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2910 |