K152305 is an FDA 510(k) clearance for the Nihon Kohden Afib Detection Program QP-039P. This device is classified as a Detector And Alarm, Arrhythmia (Class II - Special Controls, product code DSI).
Submitted by Nihon Kohden Corporation (Tokyo, JP). The FDA issued a Cleared decision on April 8, 2016, 238 days after receiving the submission on August 14, 2015.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K152305 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 14, 2015 |
| Decision Date | April 08, 2016 |
| Days to Decision | 238 days |
| Submission Type | Abbreviated |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSI - Detector And Alarm, Arrhythmia |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1025 |