The following data is part of a premarket notification filed by Nihon Seimitsu Sokki Co., Ltd. with the FDA for Model Ws-500 Digital Wrist Blood Pressure Monitor.
| Device ID | K003444 |
| 510k Number | K003444 |
| Device Name: | MODEL WS-500 DIGITAL WRIST BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | NIHON SEIMITSU SOKKI CO., LTD. 222 INSTITUTE ST. Smithfield, VA 23430 |
| Contact | Robert D Waxham |
| Correspondent | Mark Job TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2000-11-06 |
| Decision Date | 2000-11-21 |