The following data is part of a premarket notification filed by Nihon Seimitsu Sokki Co., Ltd. with the FDA for Model Ds-1901 Digital Blood Pressure Monitor.
| Device ID | K050697 |
| 510k Number | K050697 |
| Device Name: | MODEL DS-1901 DIGITAL BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | NIHON SEIMITSU SOKKI CO., LTD. 203 MAIN STREET, 166 Flemington, NJ 08822 |
| Contact | Lynette Howard |
| Correspondent | Patricia L Murphy KEMA QUALITY B.V. 4377 COUNTY LINE ROAD Chalfont, PA 18914 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-03-18 |
| Decision Date | 2005-03-25 |
| Summary: | summary |