The following data is part of a premarket notification filed by Nihon Kohden Corporation with the FDA for Nihon Kohden Afib Detection Program Qp-039p.
| Device ID | K152305 |
| 510k Number | K152305 |
| Device Name: | Nihon Kohden Afib Detection Program QP-039P |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | NIHON KOHDEN CORPORATION 1-31-4 NISHIOCHIAI, SHINJUKU-KU Tokyo, JP 161-8560 |
| Contact | Tom Bento |
| Correspondent | Thomas Bento NIHON KOHDEN AMERICA, INC. 15353 BARRANCA PARKWAY Irvine, CA 92618 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-14 |
| Decision Date | 2016-04-08 |
| Summary: | summary |