The following data is part of a premarket notification filed by Nihon Seimitsu Sokki Co., Ltd. with the FDA for Digital Blood Pressure Monitor, Model Ds-1862.
| Device ID | K040309 |
| 510k Number | K040309 |
| Device Name: | DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-1862 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | NIHON SEIMITSU SOKKI CO., LTD. PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm NIHON SEIMITSU SOKKI CO., LTD. PO BOX 7007 Deerfield, IL 60015 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-09 |
| Decision Date | 2004-02-24 |
| Summary: | summary |