K193177 is an FDA 510(k) clearance for the CER-S. This device is classified as a Electrocardiograph, Ambulatory, With Analysis Algorithm (Class II - Special Controls, product code MLO).
Submitted by Cardiocalm (Montichiari, IT). The FDA issued a Cleared decision on August 26, 2020, 282 days after receiving the submission on November 18, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2800.
| 510(k) Number | K193177 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 2019 |
| Decision Date | August 26, 2020 |
| Days to Decision | 282 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MLO - Electrocardiograph, Ambulatory, With Analysis Algorithm |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2800 |