The following data is part of a premarket notification filed by Nihon Seimitsu Sokki Co., Ltd. with the FDA for Wrist Blood Pressure Monitor, Model Ws-1100/ws-1100pv.
| Device ID | K080177 |
| 510k Number | K080177 |
| Device Name: | WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | NIHON SEIMITSU SOKKI CO., LTD. 3F, 2-17-6 AKEBONO-CHO Tachikawa- Shi, JP 190-0012 |
| Contact | Koji Kobo |
| Correspondent | Koji Kobo NIHON SEIMITSU SOKKI CO., LTD. 3F, 2-17-6 AKEBONO-CHO Tachikawa- Shi, JP 190-0012 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-24 |
| Decision Date | 2008-05-09 |
| Summary: | summary |