The following data is part of a premarket notification filed by Nihon Seimitsu Sokki Co., Ltd. with the FDA for Blood Pressure Monitor.
| Device ID | K112691 |
| 510k Number | K112691 |
| Device Name: | BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | NIHON SEIMITSU SOKKI CO., LTD. 6-5-3 BEAUNE HONKOMAGOME 2F HONKOMAGOME Bunkyo-ku, Tokyo, JP 113-0021 |
| Contact | Koji Kubo |
| Correspondent | Koji Kubo NIHON SEIMITSU SOKKI CO., LTD. 6-5-3 BEAUNE HONKOMAGOME 2F HONKOMAGOME Bunkyo-ku, Tokyo, JP 113-0021 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-15 |
| Decision Date | 2012-02-24 |
| Summary: | summary |