K191331 is an FDA 510(k) clearance for the Life Sensor Cardiac Monitor. This device is classified as a Transmitters And Receivers, Physiological Signal, Radiofrequency (Class II - Special Controls, product code DRG).
Submitted by Braveheart Wireless, Inc. (Nashua, US). The FDA issued a Cleared decision on June 12, 2019, 27 days after receiving the submission on May 16, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2910.
| 510(k) Number | K191331 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 2019 |
| Decision Date | June 12, 2019 |
| Days to Decision | 27 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 |