K160840 is an FDA 510(k) clearance for the ECG100+, ECG200+. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Cardioline S.P.A (Spini Di Gardolo, IT). The FDA issued a Cleared decision on August 12, 2016, 137 days after receiving the submission on March 28, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K160840 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 2016 |
| Decision Date | August 12, 2016 |
| Days to Decision | 137 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DPS - Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2340 |