The following data is part of a premarket notification filed by Nihon Seimitsu Sokki Co., Ltd. with the FDA for Unisonic Electronic Digital Bp Monitor Ebm-2050.
| Device ID | K850316 |
| 510k Number | K850316 |
| Device Name: | UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-2050 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | NIHON SEIMITSU SOKKI CO., LTD. 1125-7 SEKISHITA Shibukawa-shi, Gunma-ken, JP 377-0293 |
| Contact | Saitoh |
| Correspondent | Saitoh NIHON SEIMITSU SOKKI CO., LTD. 1125-7 SEKISHITA Shibukawa-shi, Gunma-ken, JP 377-0293 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-25 |
| Decision Date | 1985-04-16 |