K182040 is an FDA 510(k) clearance for the Coala Heart Monitor. This device is classified as a Transmitters And Receivers, Electrocardiograph, Telephone (Class II - Special Controls, product code DXH).
Submitted by Coala Life AB (Stockholm, SE). The FDA issued a Cleared decision on February 8, 2019, 193 days after receiving the submission on July 30, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2920.
| 510(k) Number | K182040 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 2018 |
| Decision Date | February 08, 2019 |
| Days to Decision | 193 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXH - Transmitters And Receivers, Electrocardiograph, Telephone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2920 |