K243837 is an FDA 510(k) clearance for the iBSM. This device is classified as a Transmitters And Receivers, Physiological Signal, Radiofrequency (Class II - Special Controls, product code DRG).
Submitted by Iorbit Digital Technologies Private Limited (Bangalore, IN). The FDA issued a Cleared decision on May 16, 2025, 154 days after receiving the submission on December 13, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2910.
| 510(k) Number | K243837 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 2024 |
| Decision Date | May 16, 2025 |
| Days to Decision | 154 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 |