K122356 is an FDA 510(k) clearance for the ALIVECOR HEART MONITOR FOR IPHONE. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by AliveCor, Inc. (San Francisco, US). The FDA issued a Cleared decision on November 19, 2012, 108 days after receiving the submission on August 3, 2012.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K122356 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 2012 |
| Decision Date | November 19, 2012 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DPS - Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2340 |