K211822 is an FDA 510(k) clearance for the LifePath Remote Patient Monitoring Platform. This device is classified as a Transmitters And Receivers, Physiological Signal, Radiofrequency (Class II - Special Controls, product code DRG).
Submitted by Elastic Care Incorporated (Markham, CA). The FDA issued a Cleared decision on February 3, 2022, 234 days after receiving the submission on June 14, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2910.
| 510(k) Number | K211822 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 2021 |
| Decision Date | February 03, 2022 |
| Days to Decision | 234 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 |