The following data is part of a premarket notification filed by Nihon Seimitsu Sokki Co., Ltd. with the FDA for Automatic Digital Electronic Wrist Blood Pressure Monitor Model Number Ws-300.
| Device ID | K981702 |
| 510k Number | K981702 |
| Device Name: | AUTOMATIC DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR MODEL NUMBER WS-300 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | NIHON SEIMITSU SOKKI CO., LTD. 222 INSTITUTE ST. Smithfield, VA 23430 |
| Contact | Robert D Waxham |
| Correspondent | Robert D Waxham NIHON SEIMITSU SOKKI CO., LTD. 222 INSTITUTE ST. Smithfield, VA 23430 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-14 |
| Decision Date | 1999-03-05 |
| Summary: | summary |